Job Summary
An exciting opportunity has arisen for a Design Assurance Engineer to join a leading medical device organisation on a 12-month contract. This role offers exceptional exposure to New Product Development (NPD), validation, and sustaining engineering within a highly regulated environment.
You will work as part of a cross-functional team, playing a key role in ensuring product quality, regulatory compliance, and successful delivery from concept through to commercialisation and post-market support.
Key Responsibilities
Support and contribute to design assurance activities across NPD and sustaining engineering projects
Guide cross-functional teams through design controls, risk management, and verification & validation (V&V)
Collaborate with R&D and Manufacturing teams on product transfer and process validation activities
Ensure compliance with ISO 13485, FDA, and global regulatory standards
Contribute to CAPA activities, customer complaints, and post-market surveillance
Support execution of process, equipment, and product validation
Analyse technical data to support quality improvements and informed decision-making
Requirements
Degree in Engineering, Quality Assurance, or related discipline
3–5 years’ experience as a Design Assurance Engineer within medical devices or a regulated environment
Strong knowledge of design controls, validation, risk management, and regulatory requirements
Proven ability to work cross-functionally and contribute to multiple projects in a fast-paced environment
What’s on Offer
Competitive salary and comprehensive benefits package and a 4-day working week
Opportunity to gain end-to-end NPD experience
Exposure to cutting-edge technologies in a high-performing, collaborative culture
What’s Next?
If you’re interested in this opportunity, apply now or contact Tina at Sigmar Recruitment for a confidential discussion.
Send your CV today to explore this opportunity and take the next step in your Design Assurance career within the medical device sector.
