Manufacturing Engineer

Kennedy Executive Benelux; Utrecht; On-site; EUR 70,000 - 90,000; Full time

Job summary

A medical technology company in Utrecht is seeking a Manager Manufacturing, NPI & Design Transfer to ensure smooth transitions from product design to large-scale production. The ideal candidate will have over 10 years of experience in medical devices, strong leadership skills, and a background in Design Transfer and process validation. This full-time position offers an opportunity to lead teams in a regulated environment and ensure compliance with medical device standards.

Qualifications

• 10+ years of experience in medical devices or high-tech manufacturing, including leadership experience.
• Strong background in Design Transfer, NPI, and process validation.
• Structured, communicative, and quality-driven with a hands-on approach.

Responsibilities

• Lead the transfer of new and updated designs from R&D to production.
• Manage production and engineering teams to improve product quality and yield.
• Coordinate verification and validation planning and execution.

Skills

Leadership

Process validation

Continuous improvement

Technical compliance

Education

Bachelor’s or Master’s degree in Mechanical, Electrical, or Biomedical Engineering

Tools

Medical device regulations

Job 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.

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 [e-mail] if you'd like to know more.