Job Overview
We are seeking a Design Assurance Engineer to support the lifecycle of commercially released medical device products. This key role involves managing design changes, ensuring continued compliance with global standards, and supporting post-market activities such as complaint investigations.
Key Responsibilities:
* Provide design assurance input on sustaining engineering projects across the full product lifecycle.
* Lead and execute product/material design changes in compliance with global regulatory and quality system requirements.
* Assess changes for design, usability, sterilisation, biocompatibility, and clinical impact.
* Support process changes in collaboration with R&D and Manufacturing Engineering teams.
* Maintain and update risk management files per ISO 14971 and FDA guidelines.
* Generate and execute Design Verification (DV) plans, protocols, and reports.
* Ensure compliance with design control requirements.
* Maintain design history files (DHF) and ensure full traceability of design documentation.
* Support complaint investigations, root cause analysis, and implementation of CAPAs.
* Stay informed on evolving regulatory requirements affecting product design and development.
* Provide technical input into material specs, inspection criteria, drawings, and manufacturing documentation.
* Contribute to regulatory submissions and audit preparation by providing design assurance documentation.
* Collaborate across departments to document and implement product changes.
* Champion continuous improvement initiatives within the design assurance function.
* Mentor junior engineers when required.
Qualifications & Experience:
* Bachelor's degree in Engineering, Science, or a related technical discipline.
* 2–3 years' experience in design assurance, quality engineering, or product development within the medical device sector.
* Strong working knowledge of ISO 13485, ISO 14971, and FDA QSR.
* Hands-on experience with design controls, verification activities, biocompatibility, and sterilisation validations.
* Experience with post-market quality processes, including complaint handling and CAPA.
* Demonstrated ability to work independently on moderately complex projects with general supervision.
* Strong analytical, communication, and documentation skills.
* Ability to manage multiple priorities in a dynamic, fast-paced environment.
* Effective team player with the ability to influence cross-functional collaboration.