Manufacturing Engineer, Utrecht

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.

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.

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



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