Assist in design and development of new medical devices.
Conduct literature reviews, prototyping, and laboratory testing.
Support validation and verification studies.
Prepare technical documentation (design history files, risk analysis).
Work with Quality Assurance and Regulatory Affairs teams.
Support troubleshooting and continuous improvement of existing devices.
Lead end-to-end development projects for medical devices.
Manage cross-functional teams (R&D, QA, RA, Clinical, Manufacturing).
Define project timelines, budgets, and resources.
Ensure compliance with ISO 13485, FDA 21 CFR Part 11, CE MDR standards.
Oversee design transfer from R&D to manufacturing.
Interact with regulatory agencies for approvals.
Mentor and guide team members.
Competitive Salary + Performance Bonus (annual or quarterly).
Provident Fund (PF), Gratuity, and ESI (as per Indian labor law).
Medical/Health Insurance for self & dependents (family coverage in most MNCs).
Life Insurance / Accidental Insurance.
Training & Development Programs (on regulatory guidelines, device design, ISO 13485, FDA requirements).
Exposure to global projects & cross-functional teams.
Opportunity to work with cutting-edge technology (3D printing, robotics, AI in devices).
Travel opportunities (domestic & international for audits, conferences, regulatory meetings).
Paid Leaves: Casual Leave (CL), Sick Leave (SL), Privilege Leave (PL), Maternity/Paternity Leave.
Subsidized meals or food coupons (depending on company).
Transport allowance / cab facility (in large campuses).
Work-from-home flexibility (partially in some R&D or documentation-related roles).
Clear career progression path (Team Member → Senior Engineer → Lead → Manager → Senior Manager → Head of Device Development).
Professional Certifications Support (like Six Sigma, PMP, ISO Auditor, Regulatory certifications).
International exposure with USFDA, CE, MHRA, and WHO projects.