Design Quality Engineer
Phaidon EPM London
Contact person: Ines Soares
Antwerp, Belgium
Medicine and PharmaceuticalsEngineering Design ProcessDesign EngineeringDesign DocumentationDesign Control
Description
Design Quality Engineer
Belgium | Permanent | Hybrid (2-3 Days On-Site) | 40 Hours per Week Target Start: January 2027
A growing medical technology organisation is seeking a Design Documentation & Development Engineer to support the development and lifecycle management of complex regulated healthcare products. Working within a multidisciplinary environment, you'll play a key role in maintaining product documentation, supporting development activities, and ensuring compliance with global medical device regulations.The Role
You'll act as a central point between engineering, quality, regulatory, manufacturing, and external technical partners, ensuring all development documentation is complete, accurate, and audit-ready throughout the product lifecycle.Key Responsibilities
Candidates may currently be working as:
Belgium | Permanent | Hybrid (2-3 Days On-Site) | 40 Hours per Week Target Start: January 2027
A growing medical technology organisation is seeking a Design Documentation & Development Engineer to support the development and lifecycle management of complex regulated healthcare products. Working within a multidisciplinary environment, you'll play a key role in maintaining product documentation, supporting development activities, and ensuring compliance with global medical device regulations.The Role
You'll act as a central point between engineering, quality, regulatory, manufacturing, and external technical partners, ensuring all development documentation is complete, accurate, and audit-ready throughout the product lifecycle.Key Responsibilities
- Review and assess engineering and development documentation generated by internal and external stakeholders.
- Maintain product development records and ensure full traceability of technical information.
- Support design control activities, including requirements management, verification, validation, and change control documentation.
- Identify documentation gaps and coordinate follow-up actions with project stakeholders.
- Contribute to technical file maintenance and product lifecycle activities.
- Support risk management documentation in accordance with recognised medical device standards.
- Assist with documentation packages required for product testing, regulatory submissions, and clinical activities.
- Work closely with Quality, Regulatory Affairs, Operations, and Engineering teams.
- Participate in quality system activities including audits, investigations, CAPAs, and continuous improvement initiatives.
- Bachelor's or Master's degree in Engineering, Biomedical Engineering, Life Sciences, or a related technical discipline.
- 2-5 years' experience within the medical device industry.
- Previous exposure to:
- Product Development Documentation
- Design Controls
- Technical Files
- Quality Management Systems
- Risk Management
- Verification & Validation
- Working knowledge of ISO 13485, EU MDR, FDA Quality System requirements, and ISO 14971.
- Strong technical writing and document review capabilities.
- Experience supporting Class II or Class III medical devices is advantageous.
- Comfortable operating within a regulated environment and collaborating with multiple stakeholders.
Candidates may currently be working as:
- Design & Development Engineer
- Design Assurance Engineer
- Quality Engineer
- Quality & Regulatory Specialist
- Technical Documentation Specialist
- Product Development Engineer
- Compliance Engineer
- Risk Management Engineer
- Medical Device Project Engineer
- Permanent position with a January 2027 start.
- Hybrid working model (2-3 days on-site).
- Opportunity to work on highly regulated, technically complex healthcare products.
- Exposure to product development, quality, regulatory, and manufacturing functions.
- Strong long-term growth and development opportunities within an expanding organisation.