New Product Development (NPD) Manager

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 14971).
• 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.