Job details
What you will do-
- Lead Design Assurance activities across multiple NPD programs and drive risk management (ISO 14971), usability engineering, and design controls
- Provide guidance on complex technical and quality decisions and mentor junior engineers and influence cross-functional teams
- Act as DAE Functional Lead (FL) for key programs
- Ensure timely completion of Design reviews (DRs); Risk management deliverables (RMP, DFMEA, RT, etc.) and Verification & validation strategy
- Proactively identify and mitigate program risks and partner with PD, Clinical, Regulatory, Quality, and Operations
- Influence decisions without authority and drive alignment on design inputs, outputs, and usability strategy
- Lead or contribute to Process improvement initiatives; improve DAE processes, templates, and ways of working and support audits and regulatory inspections
- Drive usability strategy across programs and Ensure integration of user needs into product design
- Lead/guide formative and summative evaluations
What you will need-
Required-
- Bachelor’s/Master’s in Engineering (Mechanical preferred); relevant experience in medical device / regulated industry
- Experience- 7 years - 10 years
- Strong knowledge of Design Controls (21 CFR 820 / ISO 13485); Risk Management (ISO 14971) and Usability (IEC 62366)
Preferred-
- Good communication and interpersonal skills.
- Exposure to Engineering Drawing, GD&T, Manufacturing process of metals and plastics.
