Medtech Development Program Manager

Our client is one one of the pioneers and trusted surgical solutions and medtech companies. They export to more than 80 countries worldwide and collaborate with hospitals, governments, and healthcare systems worldwide to strengthen surgical ecosystems and improve patient lives.The New Product Development Manager leads the development and industrialization of surgical consumable products — such as disposable instruments, delivery systems, and sterile components — ensuring regulatory compliance, cost efficiency, and scalable manufacturability. This role connects R&D innovation, process development, and quality-compliant manufacturing to bring new medical devices from concept to market-ready production.Key Responsibilities1. Product Development & IndustrializationLead 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 ReadinessDrive 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 ComplianceEnsure 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 LeadershipLead 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 & InnovationPromote 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.Candidate ProfileDegree 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 SkillsExpertise 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).