W2 only, no C2C or third parties, please!!

We’re seeking a Senior Design Controls Engineer with 10+ years’ experience in combination product development (e.g., injectables, auto-injectors, inhalers, implants). You will lead design controls, risk management, requirements traceability, and V&V activities, ensuring compliance with FDA, ISO, and ICH standards.

• Lead design control implementation per FDA 21 CFR 820.30 and ISO 13485
• Manage DHF for devices like prefilled syringes, inhalers, wearable injectors
• Develop and execute V&V strategies per ISO 11608, IEC 62366
• Drive risk management per ISO 14971 (FMEA, FTA, URRA)
• Apply Quality by Design (QbD) per ICH Q8–Q10
• Ensure regulatory compliance (21 CFR Part 4, EU MDR, etc.)
• Provide mentorship and support regulatory audits and filings (IND, NDA, 510(k), PMA)

• BS/MS in Engineering (Mechanical, Biomedical, Systems, Chemical)
• 10+ years in design assurance or quality for combination products
• Expertise in FDA/ISO/ICH regs, traceability tools (Jama, DOORS), and documentation systems (Veeva, MasterControl)

CQE, Six Sigma, PMP, CHFP