Manufacturing Engineer
Role description
Our client is developing, producing, and marketing an innovative and sustainable technology for use in the cardiac surgery setting, focused on improved temperature control and disinfection.
Om in aanmerking te komen voor een sollicitatiegesprek, dient uw sollicitatie volledig in lijn te zijn met de functiespecificaties zoals hieronder beschreven.
As the company rapidly scales up production and prepares for broader international market adoption, they are strengthening their engineering organization with leaders who can ensure manufacturing excellence, mature industrialisation processes, and a smooth transfer from design into stable, scalable production.
As Manager Manufacturing, NPI & Design Transfer , you ensure a smooth transition from product design to reliable and scalable production. You lead product industrialisation and design transfer for medical systems, connecting R&D, Quality, and Manufacturing to guarantee technical quality, compliance, and efficient production readiness.
Key Responsibilities
- Lead the transfer of new and updated designs from R&D to production.
- Ensure manufacturability, process validation, and documentation readiness.
- Oversee New Product Introduction (NPI) activities, from pilot build to full‑scale production.
Manufacturing Excellence
- Manage production and engineering teams to improve product quality, testability, and yield.
- Drive continuous improvement and structured problem‑solving in manufacturing processes.
- Ensure compliance with medical device regulations during production ramp‑up.
Verification & Validation Oversight
- Coordinate verification and validation (V&V) planning and execution in alignment with design and risk documentation.
- Review test results, manage deviations, and safeguard traceability.
- Support system and software testing for new product releases.
Cross-Functional Leadership
- Act as key liaison between R&D, QA, and Manufacturing.
- Provide technical direction to engineers and technicians involved in transfer and testing.
- Report on progress, risks, and overall readiness.
Profile
- Bachelor’s or Master’s degree in Mechanical, Electrical, or Biomedical Engineering (or related field).
- 10+ years of experience in medical devices or high‑tech manufacturing, including leadership experience.
- Strong background in Design Transfer, NPI, and process validation within the medical device regulatory framework.
- Structured, communicative, and quality‑driven with a hands‑on approach. xgiwjmb
Seniority level
- Mid‑Senior level
Employment type
- Full‑time
Job function
- Manufacturing, Engineering, and Quality Assurance
Industries
- Medical Equipment Manufacturing
- Machinery Manufacturing
- Manufacturing
Please contact Bart Heerdink via if you'd like to know more.
