Sr. Product Development Engineer

• Author and maintain design control documentation for combination drug-device and biologic products, including Design History Files (DHF).
• Ensure compliance with FDA, EU MDR, and internal quality standards throughout the product lifecycle.
• Support product development and technology transfer from early development through clinical and commercial manufacturing.
• Translate user needs into functional requirements and design outputs, including support of Human Factors Engineering activities.
• Develop and support design outputs, specifications, packaging, and verification activities.
• Perform risk management activities, including authoring DFMEA, UFMEA, and PFMEA.
• Contribute to requirements management, quality systems, and risk management tools/processes to support development activities.

Requirements:

• B.S. or M.S. in Engineering or related discipline.
• 5 10 years of experience in a regulated medical device or combination product environment.
• Experience with combination products, preferably strong drug delivery systems experience.
• Strong knowledge of design controls, DHF management, and product lifecycle processes.
• Experience with risk management in accordance with ISO 14971.
• Familiarity with FDA regulations, EU MDR, ISO 13485, and 21 CFR Part 820.
• Strong technical writing, communication, and organizational skills.
• Experience JAMA and Windchill software
• Ability to work independently and manage multiple projects in a fast-paced environment.