Biocomposites
Senior Design Assurance Engineer
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Senior Design Assurance Engineer
Senior Design Assurance Engineer
About Biocomposites
Biocomposites is an international medical devices company that engineers, manufactures, and markets world-leading products for infection management in bone and soft tissue. Based in Keele, UK, it has global operations across Europe, the USA, Argentina, Canada, China, and India.
As a world leader in calcium compounds and bone cements for surgical use, our products regenerate bone and target infection risks across specialties including:
- Musculoskeletal infection
- Orthopaedics
- Trauma
- Spine
- Foot and ankle
- Podiatry
- Sports injuries
Our solutions are now used in over one million procedures per annum and sold in more than 100 countries worldwide.
The Role
The Senior Design Assurance Engineer will implement design controls for medical device changes and new product developments, leading assigned regulatory projects, research projects, and technical projects.
Key responsibilities include:
- Maintaining the Design Dossier (Design History File) and related Technical Documentation according to regulatory and QMS requirements.
Responsibilities
- Compile and maintain design documentation for global products across the product lifecycle—from conception to retirement—in line with regulatory, quality, and business requirements.
- Conduct Risk Management activities, including Hazard Analysis and Risk Assessments, ensuring appropriate mitigation strategies are implemented throughout design and product lifecycle.
- Liaise with subject matter experts (SMEs) to ensure design tasks are completed within requirements and project timelines.
- Collaborate with quality, regulatory, and technical teams to assess product usability and safety, including end-user usability testing as needed.
- Provide support for design, development, and technical documentation across Quality, Technical, Research, and Regulatory Affairs teams.
- Ensure compliance with regulations and standards during internal and external audits, inspections, and regulatory assessments.
- Where required, stand in for the R&D Design Assurance Manager as needed.
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Experience & Qualifications
- Bachelor’s degree in Mechanical Engineering, Life Sciences, or equivalent.
- 5+ years of design control or design/research project management in a regulated environment.
- Strong project management skills with an ability to work under tight deadlines.
- Proficient in ISO 13485 (medical device regulations).
- A motivated individual eager to develop a career in the design of medical devices.
- Proficient in Microsoft Office.
- Excellent communication skills for internal/external collaboration (stakeholders, customers, team members).
- Desirable: Experience in medical devices, pharma, automotive, or aerospace manufacturing.
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Culture & Values at Biocomposites
What We Offer
- Competitive salary and benefits
- A culture that grows talent—opportunities to thrive and advance
- "One Biocomposites" philosophy, fostering:
- Engagement and inclusion
- Diverse perspectives
- Team collaboration to transform outcomes and make a positive impact
Who We Look For
- Passionate people who deeply believe in our mission.
- Open-minded individuals interested in evolving work practices.
- Teams who champion collaboration, innovation, and a commitment to bettering patient lives.
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