New Product Development

Role & responsibilities:

1. Product Development & Industrialization

• Lead the end-to-end NPD process for surgical consumables from concept design and prototyping to process validation and market release.
• Translate clinical and user needs into robust design specifications, aligned with technical and commercial goals.
• Ensure design transfer to manufacturing by developing scalable and validated production processes (ISO 13485, FDA 21 CFR 820).
• Oversee creation and maintenance of Design History Files (DHF), Device Master Records (DMR), and Risk Management Files (ISO
• Coordinate material selection, supplier qualification, and validation for injection molding, extrusion, or assembly of polymer-based consumables.

2. Scale-Up & Manufacturing Readiness

• Drive process scale-up from lab or pilot production to validated series manufacturing.
• Collaborate closely with production engineering and supply chain to optimize yield, throughput, and cost.
• Develop process validation protocols (IQ/OQ/PQ) and ensure full traceability of components and equipment.
• Identify and mitigate manufacturing risks early through DFMA (Design for Manufacturing and Assembly) and PFMEA.
• Manage technology transfer to internal or external production sites, ensuring alignment with cleanroom and quality requirements.

3. Regulatory and Quality Compliance

• Ensure all NPD activities comply with ISO 13485, MDR (EU 2017/745), and FDA QSR requirements, as well as CDSCO, and USFDA guidelines.
• Interface with QA/RA to support Technical File, CER, and submission documentation.
• Contribute to post-market surveillance and continuous product improvement.
• Support audits and inspections related to design and process controls.

4. Cross-Functional Project Leadership

• Lead multi-disciplinary teams including R&D, Quality, Regulatory, procurement, production and Business Development.
• Define project timelines, budgets, and deliverables ensuring milestones are achieved within scope and on time.
• Collaborate with external partners such as toolmakers, sterilization providers, and contract manufacturers.
• Manage design reviews, change control, and structured project documentation (PLM/QMS systems).
• Guide and mentor formulation scientists and analysts.

5. Continuous Improvement & Innovation

• Promote structured problem-solving, lean methods, and cost reduction initiatives in design and process development.
• Evaluate new materials, joining technologies, and automation concepts for future product generations.
• Drive process innovation and knowledge sharing within the team.
• Contribute to the company's innovation pipeline and technical roadmap for surgical consumables.

Preferred candidate profile

Candidate Profile

Education & Experience

• Degree in Pharmacy, Chemistry, or Life Sciences (M.Pharm / M.Sc preferred) or related discipline.
• 8–15 years of experience in medical device development, ideally in surgical consumables (e.g., catheters, tubing systems, syringes, or fluid-management devices).
• Proven record of launching innovative formulations or scaling lab-to-plant products.
• Hands-on experience with design controls, risk management, and process validation in a regulated environment.
• Strong understanding of regulatory documentation and GMP systems.

Technical Skills

• Expertise in polymer materials and processing technologies (injection molding, extrusion, welding, adhesive bonding).
• Proficient in CAD, PLM, and QMS tools (e.g., SolidWorks, Arena, MasterControl).
• Working knowledge of DFMA, FMEA, root cause analysis, and statistical validation tools (e.g., Minitab).

Soft Skills

• Strong leadership and project management capabilities with cross-functional teams.
• Hands-on leader who enjoys solving problems, building systems, and mentoring teams.
• Excellent communication skills for coordinating between technical, quality, and commercial functions.
• Analytical mindset and structured problem-solving ability.
• High attention to detail, compliance focus, and commitment to patient safety.