Design Engineer

ROM Utrecht Region; Utrecht; Hybrid; EUR 60,000 - 90,000; Full time

Job summary

ViCentra B.V. in the Netherlands is seeking a Design Engineer to design and develop medical devices from concept to manufacturable designs, ensuring safety, effectiveness, and regulatory compliance.

You will use SolidWorks to model parts, oversee prototype manufacturing, and contribute to usability and risk assessments while documenting design history, validation, and testing.

Qualifications

• Experience in designing medical devices or regulated products.
• Hands-on design and development from concept to manufacturable parts.
• Strong technical writing and documentation habits.
• Demonstrated ability to collaborate across teams and vendors.

Responsibilities

• Design and develop new medical devices from concept through final, manufacturable designs.
• Create 3D models in SolidWorks and oversee prototype manufacture.
• Provide input on assembly, manufacturability, usability, cost, and reliability.
• Write procedures and give production instructions for new products.
• Produce reports documenting the design and development lifecycle.
• Review reporting by technicians and prepare testing documentation.
• Run GMP process validations and maintain quality system docs.
• Communicate with management, peers, and vendors; stay current with relevant developments.
• 3 to 5 years designing medical devices or similar regulated products.
• Deep hands-on knowledge of small parts design and manufacturing.
• Injection moulding design/processing; start-up or scale-up experience is a bonus.

Skills

SolidWorks

Design engineering

Medical device development

Technical writing

Project management

Problem-solving

Communication

Quality assurance

Regulatory compliance

Team collaboration

Curiosity

Attention to detail

Tools

SolidWorks

Job description

ViCentra B.V. is dedicated to making life with diabetes easier by designing simple, beautiful, and effective solutions that fit people's lives. They combine technological innovation with human-centered design to empower individuals with more freedom and confidence. Their core values drive their mission to create impactful products.

As a design engineer, you will design and develop new medical devices from initial concept to final, manufacturable designs, ensuring each product is safe, effective, and meets the standards that users can trust. You will work in SolidWorks to create 3D models, oversee prototype manufacturing, and collaborate with the team on usability and safety testing, making a significant impact on the lives of those who depend on our devices.

• Design and develop new medical devices from concept through to final, manufacturable designs
• Create 3D models in SolidWorks and oversee the manufacture of prototypes
• Provide input on assembly, manufacturability, usability, cost effectiveness, and reliability of parts against product specifications
• Write procedures and give clear instructions to production for new products and assemblies
• Produce reports that document every phase of the design and development lifecycle
• Review reporting undertaken by technicians, and prepare testing and design documentation
• Run GMP process validations and complete the quality system documentation that lets new processes go live with confidence
• Communicate effectively with management, peers, and vendors, and keep current with relevant scientific and technical developments
• 3 to 5 years designing and developing medical devices — or products in a similarly regulated industry
• Deep, hands-on knowledge of designing and manufacturing small parts (fine mechanical engineering)
• Injection moulding design and processing experience, plus time in a start-up or scale-up, are both a real bonus

Skills required for the job

SolidWorks Design engineering Medical device development Technical writing Project management Problem-solving Communication Quality assurance Regulatory compliance Team collaboration Curiosity Attention to detail