Product Development Engineer (Bury St Edmunds)

Product Development Engineer – Medical Devices

We are proud to be partnering with an innovative and growing Medical Device company at the forefront of healthcare technology. We are supporting them in their search for a highly skilled and motivated Product Development Engineer to join their talented engineering team.

This is a fantastic opportunity for someone passionate about medical innovation and eager to make a real impact on patients’ lives through the development of advanced medical technologies.

Key Responsibilities:

• Drive product development projects from concept through to launch, adhering to ISO 13485 and FDA design control requirements.
• Collaborate with cross-functional teams including Quality, Regulatory, Clinical, and Manufacturing to ensure successful product delivery.
• Develop prototypes, perform testing, analyze data, and iterate designs based on technical and clinical feedback.
• Generate and maintain design documentation such as design history files (DHF), risk assessments, and technical reports.
• Support process validation and work closely with suppliers and manufacturing partners on DFM and scalability

Candidate Requirements:

• Degree-qualified in Mechanical, Biomedical, or a related engineering field.
• Previous practical experience in manufacturing, developing or testing of medical devices.
• Proficient in CAD (e.g., SolidWorks) and hands-on prototyping/testing.
• In-depth knowledge of design control processes and regulatory requirements.
• Excellent problem-solving, technical communication, and project documentation skills.

If you are ready to take the next step in your career and contribute to life-changing medical technology, we would love to hear from you.