Title: Senior Process Development Engineer
Company: Halyard Health Corporation, NYSE: HYH
Location: Irvine CA
Function: Manufacturing Operations
Reports to: Manager R&D
The incumbent will report to the Manager of Advanced Process Development R&D responsible for the medical devices business. The incumbent will be responsible for design, development, and commercialization of processes and equipment for existing products and other new medical devices. They will work with project teams and leaders to create/redefine product specifications through innovative and robust processing solutions. The incumbent will also be responsible for test development, protocols and reports related to verification and validation device testing. They will also be expected to assist in quality system compliance and regulatory filings with the FDA and other agencies outside the United States. Responsibilities:
- Provide technical leadership on new medical devices, by designing and developing manufacturing processes and related fixtures and tooling that are consistent with low defect levels and low product cost.
- Be the subject matter expert (SME) on any given project, and act as project lead to provide updates when the project leader is unavailable.
- Conferring with vendors in determining product specifications and arranging equipment, parts, or material purchase, and evaluating products according to quality standards and specifications.
- Estimating staffing requirements, production times, and relative costs to provide data for operational decisions.
- Working closely with the local manufacturing department to develop, coordinate, and implement technical training for employees.
- Creating and maintaining accurate documentation of tool drawings, design concepts, shop orders, and concepts in accordance with the R&E and quality assurance functions.
- Supporting company policies and procedures, goals and objectives, FDA regulations, and goods manufacturing practices.
- Research and purchase new manufacturing technology, work in collaboration with the local engineering department to better production equipment functionality.
- Implement the transition of new technology to make sure production continues successfully without any delays.
- Act as a mentor to junior engineers within the Process Development Group.
Interested? Please send your resume to firstname.lastname@example.org to start our process. We can then have a chat in the next few business days to discuss your fit versus your career plans.
- Bachelor’s Degree or advanced degree in Industrial, Manufacturing, Mechanical or Electrical Engineering.
- A minimum of 10+ years’ experience in a variety of technical and/or operational assignments.
- Strong experience using manufacturing analysis tools; such as but not limited to, DOE, process capability studies, six sigma etc.
- Familiar with writing validation protocols, execution and thereafter data analysis.
- Performed design transfers of new products from initial concept through launch.
- Experience with working with external service providers.
- Knowledge of engineering principles, scientific analysis, and project management.
- Must be a good communicator-written and verbal.
- A second language-Spanish would be an advantage.
- Comfortable with giving technical presentations within and outside of Halyard Health.
- Ability to prioritize multiple projects.
- Must be able to work in a team environment and meet deadlines.
- Willing to travel.
Additional Preferred Qualifications:
- Master’s Degree in Engineering.
- Experience in medical device manufacturing assembly processes including but not limited to-PU balloon forming, RF tipping equipment, Pad printing, UV/Thermal adhesive dispensers, vision systems and leak testing equipment.
- Knowledge of polymer processing techniques.
- Strong knowledge and background in mechanical engineering, with a strong ability to translate that knowledge into execution of process capabilities in major projects.
- Green Belt in Lean Principles-Black Belt a Plus.
- Ability to grasp modern technologies quickly.
- Working knowledge of solid modeling (Solid Works preferred).
- Working knowledge of Microsoft application-Word, Excel, PowerPoint etc.
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, sexual orientation, gender identity or any other characteristic protected by law.