KH
Senior Process Development Engineer
Katalyst Healthcares & Life Sciences
- 🇺🇸 United States
- On-site
- Senior
- 5 hours ago
- Risk Management
5 hours ago
Not enough detail in this posting to match
We are seeking 5 Mid to Senior Process Development Engineers with 10+ years of medical device experience to lead the development and commercialization of innovative drug delivery devices, including needle protection systems, fluid transfer devices, pen injectors, auto-injectors, and micro-infusion pump systems.
The engineer will provide technical leadership across the full product development lifecycle, from concept and design through verification, validation, regulatory approval, and commercialization.
Roles & Responsibilities :
- Lead cross-functional teams in the design and development of mechanical and electro-mechanical medical devices.
- Drive products from concept through commercialization, including verification, validation, and regulatory submissions.
- Develop engineering specifications, design documentation, project plans, test protocols, and validation plans.
- Support design controls, risk management, process validation, and continuous improvement initiatives.
- Collaborate with Marketing, Operations, Quality, and R&D teams.
- Provide technical leadership and mentor junior engineers.
- Support FDA and international regulatory submission activities.
- 10+ years of medical device engineering experience.
- Strong experience with electro-mechanical medical device design and commercialization.
- Proven experience leading products through FDA 510(k), PMA, and CE Mark approvals.
- Strong knowledge of design controls, risk management, verification, validation, and quality systems.
- Experience leading cross-functional engineering/product development teams.
Senior Process Development Engineer · Katalyst Healthcares & Life Sciences