Manager- New Product Development

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

• Strong 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).