Senior Process Development Engineer

Summary 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.

Education & Experience

• 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.