Sr. Product Development Engineer

Qualifications

• B.S. or M.S. in Engineering or related discipline
• 5-10 years of experience in regulated medical device or combination product environment
• Experience with drug delivery systems and combination products
• Strong knowledge of design controls and product lifecycle processes
• Proficient in risk management per ISO 14971
• Familiarity with FDA regulations, EU MDR, ISO 13485, and 21 CFR Part 820
• Excellent technical writing and organizational skills
• Proficiency in JAMA and Windchill software

Responsibilities

• Author and maintain design control documentation for drug-device and biologic products
• Ensure compliance with FDA, EU MDR, and internal quality standards
• Support product development from early phases to commercial manufacturing
• Translate user needs into functional requirements and design outputs
• Develop design outputs, specifications, packaging, and verification activities
• Perform risk management activities including DFMEA, UFMEA, and PFMEA
• Contribute to quality systems and risk management processes