Senior Engineer, Design Assurance
BengaluruFull-time3–6 yrsPosted over a month ago
Mid-level audit role at Beckman Coulter in Bengaluru. Needs 3+ years and a B.Tech or B.E..
About the role
The Senior Engineer, Design Assurance is responsible for providing critical quality engineering support throughout the product lifecycle, ensuring medical device designs remain safe, effective, compliant, and aligned with user needs and business objectives.
What you'll do
- Responsible for providing critical quality engineering support throughout the product lifecycle, ensuring medical device designs remain safe, effective, compliant
- Manage and maintain the Design History File (DHF)
- Perform routine DHF audits to ensure continuous compliance
- Review and approve design requirements (PDR/Requirements Matrix) and design changes (Change Orders) to ensure appropriate validation and verification (V&V) requirements…
- Collaborate cross-functionally to create and maintain risk management files and documents
What you need
- Risk management
- Compliance
- GD&T
- Six Sigma
- Audit
- FMEA
Good to have
- Root cause analysis