Tag Archives: medical device

JOB: Assoc. Director of Global Product Safety

KC-Unleash

Title:  Assoc. Director Global Product Safety

Job #160000S3, Kimberly-Clark Corp.

Location: Neenah WI just south of Green Bay (live here – https://www.youtube.com/embed/ljQ6240Klvc)

Function: Global Product Safety/ Supply Chain

Reports to: Senior Director Global Product Safety

Direct reports: 12 globally

Scope: global across several Business Units

 

Global Product Safety (GPS) is currently recruiting for an Associate Director role in the Neenah, Wisconsin location. The incumbent will be responsible for the management, professional development and technical leadership of multiple global toxicology and risk assessment professionals supporting Kimberly-Clark’s global Personal Care; Adult Feminine Care, Baby Child Care and Family Care business sectors. These businesses provide a wide array of innovative solutions and essential branded products manufactured and/or distributed by Kimberly-Clark Corporation (KCC).

 

In addition to management, corporate strategy and business support responsibilities, the incumbent will be personally responsible for delivering expert hazard identification, exposure characterization, safety assessment and product safety testing guidance to project teams and senior management. This detailed work will enable new product development, mergers and acquisitions, meet post-market surveillance requirements and promote product stewardship in support of all of KCCs business sectors.

 

The incumbent will also lead and contribute significantly in efforts to plan, design, develop and execute projects in support of medical device, drug, cosmetic and consumer product safety, quality and effectiveness. He/she will assist the GPS Sr. Director as part of the departmental leadership team to develop and implement strategies and assess group performance to meet technical and business plan requirements across the Enterprise.

Responsibilities:

  • The incumbent will be the lead departmental contact for internal business customers including those listed above as well as support of KC International and KC Professional sectors.
  • Individual must effectively provide team leadership, collaboration within multi-functional teams, and communicate toxicology, biocompatibility and safety information, technical position papers and human health risk assessments to internal and external technical experts as well as program and business sector leaders.
  • He/she will also represent GPS on multi-functional product development teams and serve as primary lead for assigned projects that may include representing KCC in trade association groups or other external bodies in support of the Company.
  • The incumbent will manage the design, monitoring and interpretation of in vitro / in vivo toxicology or clinical safety studies conducted under current Good Laboratory Practices (GLP) or Good Clinical Practices (GCP).
  • Using published literature sources, supplier information and/or generated data, the incumbent will author, document and communicate human health safety (risk) assessments taking into consideration identified hazard and patient or user exposure according to intended product use or foreseeable misuse.
  • He/she will also participate in the life-cycle management of KCC products through the review of post-marketing surveillance data and other information as gathered by or disclosed to the Company. This may result in the incumbent developing responses to safety-related internal or external customer inquiries and the development of safety-related statements, policies or other documentation for internal or external distribution.
  • The incumbent will manage self and team in accordance with expected KCC leadership behaviors and with a focus on building talent by enhancing their and team member’s technical, professional, leadership and communication skills through continuing education and professional development courses, attendance and participation in scientific conferences and meetings, publication of appropriate work in peer-reviewed journals and other aspects of technical and leadership development.
  • He/she will also participate on cross-departmental teams to contribute to the development or revision of departmental policies and procedures.

 

Ever wonder what it is like to belong to this global company?  Here are some reasons to join us: http://bit.ly/WorkingatKC !  K-C is known for their employee career development – about 65% of open jobs are filled internally and we hope we can unleash the power in you!

Interested in this job? You can contact Dorothy.Beach@KCC.com to receive more information on this job.   Sending your resume would jump-start our process and could lead to a screen call.

Qualifications needed: 

  • Degree in toxicology, biomedical or related field of relevant product safety experience in the design, development, regulatory clearance/approval and maintenance of medical device, drug, or cosmetic products in global markets; Bachelor’s degree with 10-15+ years of experience, or Master’s degree with 8-12+ years of relevant experience, or Ph.D. with 5-10+ years of relevant experience.
  • Demonstrated ability to lead people from diverse backgrounds and cultures and/or multi-national teams in a matrix, cross-functional or direct reporting relationship.
  • Experience in direct management of staff.
  • Certification by the American Board of Toxicology (DABT) or other equivalent scientific or medical professional certification.
  • Proficient knowledge in regulatory science and national/international quality management system requirements (e.g., ISO, USFDA) associated with the development, commercialization and manufacture of medical device products in global markets.
  • Ability to travel up to 30%, both nationally and internationally.

 

 

Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 175 countries. Every day, 1.3 billion people – nearly a quarter of the world’s population – trust K-C brands and the solutions they provide to enhance their health, hygiene, and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex, and Depend, Kimberly-Clark holds No.1 or No. 2 share positions in more than 80 countries. With more than 140 years of history of innovation, we believe in recruiting the best people and empowering them do their best work.  If fresh thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark.

 

 

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

Kimberly-Clark is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law.

 

 

Advertisements

Business Development and Strategy Lead for new Healthcare BU

KC-Unleash

Title:   Business Development and Strategy Lead for Sofusa™

Job #150002YQ, Kimberly-Clark Corp.

Location: Sandy Springs GA or anywhere in SE near large city

Function: Global Sector Marketing & Innovation

Reports to: VP

Direct reports: to be determined – new role

Product Line: Sofusa™ DoseDisc™

Scope: initially US but will go global 

Kimberly-Clark, with five billion-dollar brands, has a strong legacy of innovation backed by our proprietary technologies.  Most recently, the company has developed the first-of-a-kind Sofusa™ DoseDisc™ System for transdermal delivery of liquid formulations of proteins, peptides and small molecules.  Unlike prefilled syringes, auto-injectors and pens that provide one delivery option (bolus), the Sofusa™ DoseDisc™ System is designed to provide drug developers a range of controlled delivery options without requiring reformulation.  Simple-to-administer and pain-free for patients, the Sofusa™ DoseDisc™ system has been approved by US FDA for two INDs.  A qualified supply chain is in place and scale-up of cGMP production is underway.  A successful Phase I clinical trial was completed in 2014.

Purpose of this New Role:

Lead the development and execution of strategic engagements with external organizations to drive growth and profitability for the Sofusa™ business unit. Target 2-4 deals per year to deliver net sales of $500MM by 2020 and $2B by 2025.  Lead negotiations with external parties as well as processes within K-C to identify, qualify and close agreements.

Role Accountabilities:

 

Build relationships in the industry

  • Build Sofusa™ brand and technology awareness in the Pharma industry and with targeted contacts (commercial, R&D, BD&L) at key prospects.
  • Create  a positive perception in the industry of K-C as a collaborator and the first choice for transdermal drug delivery.
  • Lead development of enduring, multi-functional and multi-level relationships (strategic relationship management).

 

Lead search and evaluation for strategic partners for the Sofusa™ technology

  • Working with Sofusa™ BU leadership and technology resources, prioritize new product opportunities consistent with the business’ objectives.
  • Identify and qualify strategic relationships to develop/commercialize new product opportunities.
  • Develop and present a compelling proposition for the Sofusa™ technology platform and new product opportunities to prospective partners.

 

Lead negotiations with prospective partners and lead K-C internal process(es) resulting in Agreements that meet the needs of all stakeholders.

  • Lead, negotiate and close Deals that enable achievement of Sofusa™ business objectives, including effectively managing term sheet process, Contract/Agreement development, financial analytics, and risk analyses.
  • Lead deal approval process within K-C including directing cross-functional team  (Legal, Finance, etc.) and gaining necessary approvals from senior leadership
  • Prepare diligence materials and oversee the due diligence process.

 

Provide direction and business leadership to the Sofusa™ business

  • Contribute to strategic and annual planning processes for the business.
  • Work with technical and operations leaders to ensure commercial plans and objectives are mutually supportive
  • Achieve business objectives including: revenue, costs and operating profit plus capital and SG&A management

 

Business Priorities:

  • Cultivate and close Pharma deals
  • Develop strong long-term relationships with Pharma
  • Build positive perception of Kimberly-Clark in the Pharma industry
  • Contribute to the development of a winning culture in the Sofusa™ business

 

Ever wonder what it is like to belong to this global company?  Here are some reasons to join us: http://bit.ly/WorkingatKC !  Interested in this job? You can contact Dorothy.Beach@KCC.com to receive more information on this job.   Sending your resume would jump-start our process and could lead to a screen call.

 

Qualifications:

  • Bachelor’s Degree
  • 10+years business development & licensing experience in the Pharma industry
  • 10+years conducting and concluding contract negotiations in the Pharma industry; strong preference for U.S. and int’l experience.
  • Solid understanding of global Pharma industry (companies, products, pipeline, trends, issues/opportunities), business development strategies and tactics,  market dynamics and stakeholder requirements.
  • Experience in gaining the support and backing of senior leaders.

 

Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 175 countries. Every day, nearly a quarter of the world’s population trust K-C’s brands and the solutions they provide to enhance their health, hygiene and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex and Depend, Kimberly-Clark holds No. 1 or No. 2 share positions in more than 80 countries.  With a 143-year history of innovation, we believe in recruiting the best people and putting them in the right jobs so that they can do their best work. If fresh thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark. 

 

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

Kimberly-Clark is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law.

 

Engineering and Manufacturing Operations Leader | New Tech Platform

KC-Unleash

Title:  Engineering and Manufacturing Operations Leader for Sofusa

Company: Kimberly-Clark Corporation, job #150002XC

Location: Sandy Springs GA just south of Roswell GA

Function: Corporate Innovation

Reports to: VP of Science and Technology

Product Line: DoseDisc

 

Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 175 countries. Most recently, the company has developed the first-of-a-kind Sofusa™ DoseDisc™ System for transdermal delivery of liquid formulations of proteins, peptides and small molecules.  Unlike prefilled syringes, auto-injectors and pens that provide one delivery option (bolus), the Sofusa™ DoseDisc™ System is designed to provide drug developers a range of controlled delivery options without requiring reformulation.  Simple-to-administer and pain-free for patients, the Sofusa™ DoseDisc™ system has been approved by US FDA for two INDs.  A qualified supply chain is in place and scale-up of cGMP production is underway.  A successful Phase I clinical trial was completed in 2014.

Purpose of the Role:

Provide engineering and manufacturing operations leadership to support the delivery of $500MM net sales by 2020 and $2B by 2025 at targeted costs. Ensure FDA/Global regulatory approvals, and commercial supply of the Sofusa™ combination product for multiple drug candidates.

 

Role Accountabilities:

 

  • Deliver a Continuous Supply of Sofusa™ Combination Products
  • Lead the design, engineering, purchase, installation, start-up, and validation of all required manufacturing equipment with external CMOs.
  • Lead all operation responsibilities of the Sofusa™ supply chain including costs, quality, inventory, working capital, and safety.
  • Lead site operations at the Sandy Springs manufacturing facility.
  • Support all development, FDA approval, and commercial supply needs.
  • Lead all FDA/Global regulatory GMP documentation requirements for applications and audits.
  • Develop supply chain vendor options for multi-sourcing and supporting capital plans
  • Work with Procurement on all supply agreements.
  • Support FDA Audits.
  • Build Pathways for Commercialization
  • Evolve and build network of suppliers and CMO’s to ensure that Sofusa™ has access to capabilities necessary for success
  • Develop relationships with Pharma partners to support clinical trials and successful commercialization
  • Identify opportunities to streamline supply chain
  • Build Safety and FDA Compliance as a Core Culture
  • Execute LEAN and World Class Manufacturing Principles.
  • Business Priorities
  • Meet quality and safety specifications
  • Uninterrupted supply.
  • Achieve target costs
  • Successful Pharma partnerships
  • Contribute to the development of a winning culture in the Sofusa™ BU
  • Develop, implement and maintain capital budget and system for developing strategy
  • Develop strategy for equipment needs for startup and manufacturing of product

Ever wonder what it is like to belong to this global company? Here are some reasons to join us: http://bit.ly/WorkingatKC .  Interested in being a part of a new BU?  Sending your resume can jump-start our process to – Dorothy.Beach@KCC.com.

Qualifications:

  • Bachelor’s Degree with engineering discipline preferred.
  • 10+years experience in commercial production of FDA regulated combination products (Drug Delivery highly preferred).
  • 10+years experience in the design, engineering, start-up, and validation of commercial equipment used in the production of combination products.
  • Strong knowledge of all requirements and validation activities necessary for GMP manufacturing of a combination product.
  • Strong knowledge of manufacturing equipment procurement and capital strategy development and maintenance.
  • Proven ability to perform in cross-functional teams, manage global suppliers and lead contract manufactures (CMOs).
  • Experience in gaining the support and backing of senior leaders for capital strategies and investment plans.
  • Good communication skills to multiple audiences.

 

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position. 

Kimberly-Clark is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law.

Halyard Health hiring Plant Manager | AZ

Halyard logo

Title: Plant Manager | Nogales AZ/MEX

Company: Halyard Health, job #150002ON

Location: Nogales or Tuscon AZ to live and cross into Mexico daily

Function: Operations

Reports to: VP Product Supply

 

Position Purpose:  Lead and manage Nogales operations’ capability and performance to help Health Care achieve its net sales, operational profit and gross margin objectives by meeting product supply sector goals.

 

Customers and Customer Expectations: Customers: Customer Service function, distribution centers, and end users.  Customer Expectations:  Operations to achieve exceptional and consistent service fill rate by providing a defect-free, cost effective product, according to customer expectations.

 

Expectations:

  • Ensure that Nogales’s organization establish and meet objectives in safety, quality, cost, productivity, customer service, asset management, clarity savings, lean manufacturing, and human resource development to achieve vision 2020.
  • Product Supply manufacturing activities are integrated with Go to Market strategies.
  • Provide effective leadership to achieve Lean certification.
  • Provide leadership in the prioritization and implementation of capital budgets
  • Lead and manage a manufacturing culture based on high performance work teams.

 

Scope:  He/she has broad management responsibilities medical devices, and other manufacturing and manual processes related to product supply. The incumbent provides leadership for the Nogales operation team to meet challenges faced by manufacturing while achieving goals and objectives.  The role has line operations accountability and requires internal and external coordination of projects and programs for successfully implementation within Health Care guidelines and expectations.

 

The main challenge of this position is to effectively influence across functional areas in an integrated manner within Global Halyard to ensure successful implementation of line operations and cost saving activities.

 

Principal Accountabilities:

 

  • Maintain an accident free and safe environment for employees, customers, and suppliers working and/or visiting the plant and warehouse.
  • Provide leadership for Loss Control Management in support of sector and corporate objectives.
  • Ensure adherence to HYH Corporate and Health Care sector controls, policies and regulatory guidelines.
  • Participate in multi-functional business teams and provide leadership in the development of business unit initiatives pertaining to product lines suitable to Nogales
  • Be recognized as a change agent implementing and evolving lean manufacturing processes and high performance work teams.
  • Identify and complete continuous improvement projects to achieve vision 2020 objectives.
  • Coach functional managers and high performance work team leaders to coordinate the orientation, training and development of team members to enhance their present performance and prepare them for advancement.
  • Lead/ champion the receiving side of special projects assigned to Nogales and directed by the Sector Leadership Team.
  • Advocate system development and enhancements to support long term goals of Halyard Global Manufacturing.
  • Provide leadership for the CLARITY administration, tracking and implementation for the Nogales team.
  • Be an advocate and champion for LEAN manufacturing and Six Sigma process improvement activities.
  • Communicate fully with superiors, subordinates and others who have a need to know.  Be informative without being obtrusive or vexatious. Communicate in a way that is timely, yet prompt; complete, yet concise; candid, yet accurate; and clear, yet responsive.
  • Contribute to an environment in which all team members are respected regardless of their individual differences and are motivated to improve both their individual and team contributions to achieve desired business results.

 

 

Interested?  Please send your resume to d.beach@accenture.com to start our process. We can then have a chat in the next few business days to discuss your fit versus your career plans.

 

Qualifications/Education/Experience Required:  This position requires knowledge and ability typically associated with a bachelor’s degree. The incumbent also must have broad knowledge and significant experience in operations/ logistics/maintenance or related areas at the functional level and a working knowledge of multifunctional issues including Mexican labor law, customs regulations, EPA/OSHA regulations and their Mexican counterparts. This person requires a thorough understanding of all internal and external mill/plant functional areas and their interaction, and a proven ability to work across all staff functions. Prefer those candidates who worked in medical device manufacturing.

 

Halyard Health [NYSE: HYH] is a medical technology company focused on preventing infection, eliminating pain and speeding recovery for healthcare providers and their patients. Headquartered in Alpharetta, Georgia, Halyard is committed to addressing some of today’s most important healthcare needs, such as preventing healthcare-associated infections and reducing the use of narcotics while helping patients move from surgery to recovery. Halyard’s business segments — Surgical and Infection Prevention and Medical Devices — develop, manufacture and market clinically superior solutions that improve medical outcomes and business performance in more than 100 countries. For more information, visit http://www.halyardhealth.com. 

 

 

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

 

 

Halyard Health is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

 

Medical Device public company hiring Sr. Drafter/Designer | GA

Halyard logo

Title: Senior Drafter/Designer

Company: Halyard Health Corporation: (NYSE: HYH) #150000NN

Location: Alpharetta GA just north of Atlanta

Function: Research & Engineering

Reports to: Team Lead

Scope: Global

There may be no better place to advance your career than at Halyard Health. Join our Medical Products R&D Team in a pivotal role of a global consumer and medical products company. Halyard Health is a major global player in health and hygiene products with global-scale issues and opportunities. Please visit our website at http://www.halyardhealth.com to learn more about us.

Halyard Health offers a wealth of career growth opportunities that allows you to reach your full potential. Our collaborative team environment will provide you with an energetic and rewarding work experience that includes product design, research, product development and commercialization.  As part of a dynamic team you will be interacting with customers to identify technology opportunities within a project setting.  You will have an opportunity to move into other disciplines to broaden your business knowledge. Your technical expertise will bring innovative products that enhance the health, and hygiene, and wellbeing of families everywhere.

Summary:  The incumbent will report to the Manager of R&E within the health care business. The incumbent will provide design and drafting support for both product development and production of health care devices. They will also be expected to assist in quality system compliance and regulatory filings with the FDA and other agencies outside the United States.  There may be some travel in and outside the country.

Job Description:

  • Mechanical/ Technical CAD Designer / Drafter with solid and recent SolidWorks part/assembly design experience
  • Create, modify, and maintain medical and surgical product drawings in SolidWorks and EnterprisePDM
  • Create and modify technical product drawings per ASME/ANSI and company standards
  • Manage all drawing administrative duties, CAD content management, and document control for multiple FDA Class I/II/III product
  • Design, optimize, and verify components and assemblies
  • Contribute to development of Standards and Processes for the Global team
  • Prototyping experience in medical/surgical products or relevant industry is desired.

 

Interested? Please send your resume to d.beach@accenture.com to start our process. We can then have a chat in the next few business days to discuss your fit versus your career plans.

Basic Qualifications: 

  • Associate degree in Technical Design minimum. Bachelor’s Degree in Mechanical, Biomedical Engineering, or related discipline preferred
  • A minimum of 5 years of medical device or related experience.
  • Proficient in SolidWorks 

 

 

Preferred skills:

  • Demonstrate exceptional current SolidWorks proficiency and 3D parametric modeling and drawing experience
  • Experience in medical device and surgical product design strongly preferred
  • Experience in design/drafting of plastic injected and extruded components and assemblies strongly preferred
  • Experience in detailed design, dimensioning, and stack-ups
  • Experience in rapid prototyping techniques, systems, and sub-contracting preferred
  • Experience in prototype lab / machine shop operations, CADCAM, Mastercam, or other machine control applications preferred
  • Experience/Familiarity with CMM and Optical measuring equipment strongly preferred
  • Experience in development and publication of standards, protocols, and processes and training strongly preferred
  • Strong desire to work in highly collaborative, customer-focused, team environment, with global development partners
  • Demonstrate exceptional verbal and written communication skills
  • Experience with migrating technical drawings from legacy CAD applications to SolidWorks
  • Design/Technical/CAD degree strongly preferred
  • Professional CAD training and certification strongly preferred
  • Must have or obtain a passport
  • Previous & recent international travel preferred
  • Spanish or Mandarin Language Skills a plus

Halyard Health [NYSE: HYH] is a medical technology company focused on preventing infection, eliminating pain and speeding recovery for healthcare providers and their patients. Headquartered in Alpharetta, Georgia, Halyard is committed to addressing some of today’s most important healthcare needs, such as preventing healthcare-associated infections and reducing the use of narcotics while helping patients move from surgery to recovery. Halyard’s business segments — Surgical and Infection Prevention and Medical Devices — develop, manufacture and market clinically superior solutions that improve medical outcomes and business performance in more than 100 countries. For more information, visit http://www.halyardhealth.com. 

 

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

 

 

Halyard Health is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

 

Job: PMP Managing Medical Device Product Development

Halyard logo

Job title:  Director of Research & Development Operations

Company: Halyard Health

Location: Alpharetta GA just north of Atlanta

Function: Research

Reports to: VP Global R&D

Product Line: Pain management

 Position Purpose & Scope of Responsibilities:

The Director of R&D Operations will lead several functions that are critical to accelerating growth for the $1.7 Billion Dollar Halyard Health organization. This leadership role, reporting to the Vice President of Global R&D, will include developing an R&D specific project management center of excellence with resources dedicated to support the product development process (PDP) and to support R&D project leaders in the execution of their projects. In addition, this position will also lead a Design for Six Sigma center of excellence including resources dedicated to support training and advanced statistics. The Director of R&D Operations will also lead several critical R&D services functions including the global design & drafting services organization, R&D lab services, strategic standardization, prototyping services and an industrial design / human factors evaluation capability.

Primary scope of duties and responsibilities includes the following:

• Ensure the utilization of project management methodologies across the R&D organization. Work in collaboration with the Corporate Strategy Execution Office to assist in the training of project leads on the necessary skill sets and move the R&D organization’s project management practices along a project management maturity model.
• Provide project mgmt. subject matter expertise and support to R&D project leaders. Build and manage a group of project analysts that will support R&D project leader activity.
• Assess issues identified by Project Leaders, Project Managers, PDP Champion and Functional Groups and identify organizational opportunities in order to improve product development.
• Support the strategic planning and R&D budgeting process and measure and monitor R&D effectiveness across the organization through the use of key R&D product, performance and process metrics. Establish a set of project scorecards that can be used by management to ascertain the health of innovation.
Own the product development process. Ensures the consistent, collaborative use and continuous evolution of solid product development processes and practices across the organization.
Own the design for six sigma training and certification process for R&D. Leverage DFSS to drive a culture change to instill focus on fact-based management practices, the use of statistical tools and other problem solving methodologies.
• Continuously improve company’s organizational capabilities to achieve process quality as part of project execution, including an awareness of the need to “do it right the first time.”
Own the global design & drafting organization that includes capabilities in industrial design and the integration of human factors. Manages the organization and ensures continuous improvement in the capabilities around human centered design and overall service level.
• Drive continuous improvement in all aspects of the laboratory operations. Ensures that all laboratory activities and operations are carried out in compliance with local, state, federal laws and regulations and company policies. Also ensure lab technicians are well trained and are mentored and supervised appropriately.
Own and manage the overall prototyping capabilities for the organization including the model shop and external 3rd party relationships.
• Attracts develop and retain top talent. Conducts performance reviews with input from project leaders, core team members, project managers and key stakeholders.
• Management of project budget and oversight of project expenses & capital expenditures
• Develop and monitor risk mitigations plans to ensure business and project objectives are met
• Support outside contract/supply agreement contract development and vendor management
• Ensures that high potential candidates are matched appropriately with stretch assignments/projects in an effort to retain top talent within Halyard Health.

Customers:

• Research and Development, Sales, Marketing, Business Strategy, Legal, Quality, Regulatory, Medical Sciences/Clinical, External Development Vendors, Finance, Product Supply, Clinicians and Key Opinion Leaders.

Expectations and Accountabilities:

• Responsibility for centers of excellence in R&D project management and design for six sigma.
• Responsibility for several key R&D support functions including global design and drafting, industrial design, prototyping services, human factors evaluation & laboratory services.
• Hire, develop, manage, mentor & coach R&D personnel in order to ensure appropriate business unit, divisional and enterprise objectives are met
• Drive data based decision making and best practices in project management planning & execution to ensure new product development activities are delivered to plan.
• Develop clear scorecards and metrics to evaluate the R&D organizations effectiveness and the health of our innovation processes.
• Prepare and implement budgets and schedules and manage both appropriately.
• Manage teams and self in accordance with the expected behaviors of the Halyard Health Leadership Qualities.
• Protect technologies and products through appropriate use of patents and trade secrets.

 

Interested? Please send your resume to D.Beach@Accenture.com to start our process. We can then have a chat in the next few business days to discuss your fit versus your career plans.

Qualifications/Education/Experience Required: 
• Education: Bachelor’s degree in Engineering or Scientific discipline (MS/PhD preferred)
• Skills / Qualifications:
o 10+ years of successful demonstrated experience in Project Management, R&D and/or product development or equivalent experience.
o Excellent written and oral communication skills
o Proven negotiation and influence skills
o Strong people and process management skills
o Strong strategic thinking skills
• Preference will be given to:
o Candidates with Black belt certification in Design for Six Sigma (DFSS) or equivalent.
o Candidates with PMP Certification through PMI or tracking to Certification
o Candidates with previous experience managing R&D services such as design and drafting
o Candidates with previous experience managing R&D technical teams.
o Candidates who have driven or been a key core team member in product development process improvement initiatives and have worked on developing and reporting R&D metrics.
o Medical Device Product Development Experience a very strong plus

 

 

Halyard Health [NYSE: HYH] is a medical technology company focused on preventing infection, eliminating pain and speeding recovery for healthcare providers and their patients. Headquartered in Alpharetta, Georgia, Halyard is committed to addressing some of today’s most important healthcare needs, such as preventing healthcare-associated infections and reducing the use of narcotics while helping patients move from surgery to recovery. Halyard’s business segments — Surgical and Infection Prevention and Medical Devices — develop, manufacture and market clinically superior solutions that improve medical outcomes and business performance in more than 100 countries. For more information, visit http://www.halyardhealth.com. 

 

 

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

 

 

Halyard Health is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

 

Job: Assoc. Director of Global Clinical Study Strategy and Operations | WI

KC-Unleash

Title:  Associate Director, Global Clinical Study Strategy & Operations  

Job #150000TI , Kimberly-Clark Corp.

Location: Neenah WI just south of Green Bay

Function: Quality Assurance, Regulatory and Compliance

Reports to: VP Global Quality and Regulatory

Position Summary:

The incumbent is responsible for establishing standard operating procedures that ensure state-of-the-art clinical expertise, assessments, trials, processes and systems are applied that not only ensure human safety, but also drive product innovation, sustainability and speed-to-market. This role provides supervision to Clinical Research Associates and the Clinical Data and Analysis team and works closely with the Clinical Project Management team who manage the overall BU clinical trial strategy and execution of clinical trials and the Global Clinical Affairs Medical Director who provides human safety and compliance input to internal procedures.

Job Responsibilities:

  • Leads a team that provides operational and data management support for clinical trials that will support the successful commercialization of new and existing products in the areas where K-C has stated claims
  • With input from Quality Control and Clinical PM team and Medical Director, design, update and implement appropriate innovative and best-in-class procedures and SOP’s related to clinical study development and execution
  • Participate as needed in the management of relations with professional and governmental organizations globally
  • Provide leadership to ensure that Clinical Affairs attracts, develops and retains the best people and fosters an environment that motivates a diverse team to fully use its capabilities in achieving desired business results
  • Responsible for the department budget

Interested? You can contact Dorothy.Beach@KCC.com to receive more information on this job.   Sending your resume would jump-start our process and allow a discussion between your career goals and what Kimberly-Clark needs.

Basic Qualifications

  • Bachelors of Science Degree with 7+ years in the device industry that includes a minimum three years direct clinical research/development engagement
  • Experience working in a global or similarly structured organization
  • Experience in the development and design of study protocols and all related documentation
  • Experience in coaching and mentoring at managerial and/or supervisory level
  • Business communication skills (e.g., verbal, written, presentation); both external and internal
  • Responsible for providing input and oversight of vendor and contractor selection and management
  • A history of success in collaborating with business teams and the functions within those teams including Marketing, Sales, R&E,  and Quality
  • Experience with the participation in cross-functional teams required

Preferred Qualifications

  • Advanced Degree (MBA, MS, or PhD).
  • Global level clinical trial experience preferred.
  • Experience in health care/medical device based business.
  • Experience with device (IDE’s and studies that have led to PMA and/or PMA supplement application and/or approvals) clinical studies

Travel: Approximately 25% of time; international travel required.

Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 63 countries. Every day, 1.3 billion people – nearly a quarter of the world’s population – trust K-C brands and the solutions they provide to enhance their health, hygiene, and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex, and Depend, Kimberly-Clark holds No.1 or No. 2 share positions in more than 80 countries. With a 135-year history of innovation, we believe in recruiting the best people and putting them in the right jobs so that they can do their best work. If fresh thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark!

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position

Kimberly-Clark is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

 

Global M&E/MRO Commodity Manager job for Halyard Health | GA

Halyard logo

Title:   Global M&E/MRO Commodity Manager

Company: Halyard Health, job #150000AN

Location: Alpharetta GA just north of Atlanta

Function: Procurement

Reports to: Manager of Procurement

 

Position Purpose:
At Halyard Health we spend $700 Million dollars with vendors every year. Our team ensures we have strong relationships with internal stakeholders so we understand the business needs and develop effective sourcing strategies that drive value and reduce risk, so Halyard Health can continue to invest in innovative new products and customer relationships.

The Procurement Senior Consultant reports to the Strategic Procurement Manager and is responsible for the timely and cost-effective strategic sourcing of the M&E and MRO categories in accordance with corporate policies and procedures. Value of spend managed typically would be in the $50 Million to $100 Million range and/ or includes a large number of suppliers (100+). Utilizing a structured sourcing process, the Procurement Senior Consultant handles category sourcing, contract negotiations and seeks opportunities for vertical integration and strategic partnerships to enable growth and ensure continuity of business. The Procurement Senior Consultant provides technical direction, advice, and counsel on a wide array of procurement issues, bringing broad depth and breadth of experience to handle buying in complex and/or rapidly changing marketplaces.

Customers:
Broad base of customers could include: Global Procurement, Business Management, Finance, A/P, Receiving, ITS, Distribution, Operations, R&E, Internal Control, Marketing, Planning, Engineering, or other personnel involved in the implementation of business strategies where sourcing plays a role.

Principal Accountabilities:

  • Develop strategic approaches for the Global M&E and MRO categories.
  • Develops thorough category strategies to drive value based on an understanding of business unit needs, the supply market, spend baseline, evolution and benchmarking. Effectively document, communicate and gain buy-in for the strategies.
  • Research, select, develop and maintain adequate sources of supply to ensure that the requirements of the categories are met with the optimum quality, service and cost to use.
  • Ability to successfully reach business objectives through supplier negotiations.
  • Analyzes market and supply dynamics related to supplier proposals to develop a matrix of negotiation scenarios. Engages business leaders to align on acceptable negotiation outcomes. Develops a negotiation tradeplan, counterarguments, opening positions, and plan for executing negotiations.
  • Leads the development of risk analyses, assessments and mitigation plans for categories of spend. Manage supplier network for assigned commodities to provide sufficient materials and services to meet highest short-range requirements, protect against temporary supply interruptions and provide for long-range growth needs. Develop and execute a plan to quickly and effectively manage any supply interruptions.
  • Interacts with stakeholders to develop, engage and lead supplier relationships for extracting the greatest value in cost, security of supply, risk management, sustainability and innovation. Manage the ongoing performance of our suppliers including objective setting and supplier evaluations where warranted.
  • Comprehend and provide constructive input on legal contract documents related to purchasing terms, conditions, indemnification, intellectual property ownership, etc.
  • Knowledgeable about the markets and how they affect price, availability, or supply chain logistics. Will use specific market analysis to predict behavior and supply risks to the organization. Will adjust strategies to minimize effect of market change.
  • May provide market analysis to customers and advice to others within procurement.
  • Forecast timely price and availability information on assigned commodities for the various consuming businesses and communicate this information to appropriate personnel in the company so it is properly integrated into business strategy and decision-making.
  • Maintain an up-to-date knowledge of corporate policies and procedures, as well as related governmental laws and regulations to ensure purchasing activities are conducted within the parameters of each.
  • Contribute to an environment in which all team members are respected regardless of their individual differences and are motivated to improve both their individual and team contributions to achieve desired business results.
  • Communicate fully with superiors, subordinates and others who have need to know in a way that is timely, complete, concise; candid, accurate; clear, and responsive. Be informative without being obtrusive or vexatious.

 

Interested?  Please send your resume to d.beach@accenture.com to start our process. We can then have a chat in the next few business days to discuss your fit versus your career plans.

Required Qualifications: 

  • Bachelor’s degree in business, engineering or related discipline
  • 10 or more years of relevant experience in M&E and MRO
  • Demonstrated knowledge and experience in procurement processes and driving business results through influence and leadership

Preferred Qualifications: 

  • Master’s Degree in Business Administration or related field
  • Experience in strategic sourcing of key direct materials
  • Commercial awareness beyond Procurement
  • Strong quantitative, cost modeling, and data analysis experience
  • Strong Supplier Relationship Management experience
  • Strong project management and process improvement experience
  • CPM or CPIM (APICS) certification
  • Purchasing system experience (SAP)
  • Six Sigma, Lean, or equivalent training

Skills

  • Excellent negotiation, interpersonal, and leadership skills
  • Strong communication and presentation skills
  • Change agent with ability to influence at all levels of the organization
  • Problem solving experience in reducing total costs, improving processes and reducing supplier risk

Halyard Health [NYSE: HYH] is a medical technology company focused on preventing infection, eliminating pain and speeding recovery for healthcare providers and their patients. Headquartered in Alpharetta, Georgia, Halyard is committed to addressing some of today’s most important healthcare needs, such as preventing healthcare-associated infections and reducing the use of narcotics while helping patients move from surgery to recovery. Halyard’s business segments — Surgical and Infection Prevention and Medical Devices — develop, manufacture and market clinically superior solutions that improve medical outcomes and business performance in more than 100 countries. For more information, visit http://www.halyardhealth.com. 

 

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

Halyard Health is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.