Location: Bengaluru, India
Department: Surgery Equipment
About the Role:
Design, develop, and validate next-generation surgical instruments and devices. Collaborate with cross-functional teams to ensure products meet performance, safety, and regulatory standards.
Key Responsibilities:
- Lead end-to-end product design, from concept through verification & validation.
- Perform FEA/CFD analyses and physical prototyping.
- Draft technical documentation and risk assessments (DFMEA).
- Support FDA/CE submissions and coordinate with QA/RA teams.
Qualifications:
- M.S. or Ph.D. in Biomedical, Mechanical, or Mechatronics Engineering.
- 5+ years in medical device design (surgical instruments preferred).
- Proficient in CAD (SolidWorks or Creo) and simulation tools.
- Strong understanding of ISO 13485 and IEC 62304.