Role & responsibilities

Lead end-to-end wound care product development from concept to commercialization. Coordinate with quality, regulatory, design, manufacturing, suppliers, and clinicians to deliver safe, cost-effective, and regulatory-compliant products.

Key responsibilities include

- Driving NPD projects through stage-gate process: design inputs, prototyping, V&V;, pilot builds, launch.
- Managing documentation (design history, test reports, change control, regulatory submissions).
- Conducting microbiology tests, validation studies, and risk management (DFMEA, hazard analysis).
- Engaging suppliers for material selection, qualification, and audits.

Tracking project timelines, budgets, and performance metrics; ensuring compliance to ISO 13485, ISO 14971, ISO 10993.

Key Performance Indicator

- NPD Stage-Gate Progress
- Design Controls & Documentation
- Verification & Validation (V&V;) Execution




- Microbiology & Biocompatibility Testing
- Risk Management (DFMEA & Hazard Analysis)
- Supplier & Material Qualification
- Regulatory Compliance (ISO 13485/14971/10993)
- Project Timeline Adherence

Competencies / Functional & Technical Skills

- Solid knowledge of polymers and biopolymers, microbiology, product lifecycle, manufacturing processes, and regulatory standards.
- Hands-on experience in test protocols, risk management, and prototyping.
- Excellent project management, cross-functional coordination, and leadership skills.

Qualication

- Masters in Life Sciences, Bioengineering, Microbiology, or related field.

Work Experience

- 8-12 years of NPD/R&D; experience in medical devices (wound care preferred).

📌 Manager- New Product Development (Bengaluru)
🏢 Healthium Medtech
📍 Bengaluru