Senior Design Assurance Engineer
Biocomposites is an international medical devices company that engineers, manufactures, and markets world‑leading products for use in infection management in bone and soft tissue. Based in Keele, UK, it has global operations across Europe, USA, Argentina, Canada, China, and India. Biocomposites is a world leader in the development of innovative calcium compounds and bone cements for surgical use. Its products regenerate bone and target infection risks across a variety of specialties, including musculoskeletal infection, orthopaedics, trauma, spine, foot and ankle, podiatry, and sports injuries. Biocomposites products are now used in over one million procedures per annum and sold in more than 100 countries around the world.
The Senior Design Assurance Engineer will be responsible for implementing design controls for medical device changes and new product developments, leading assigned regulatory projects, research projects and technical projects. This will include maintaining the Design Dossier (Design History File) and related Technical Documentation according to regulatory and QMS requirements.
Responsibilities
* Compilation and maintenance of design documentation for global products across the product lifecycle, from product conception through to retirement in accordance with specified regulatory, quality and business requirements.
* Conduct Risk Management activities, including Hazard Analysis and Risk Assessments, ensuring appropriate risk mitigation strategies are implemented throughout the design process and product lifecycle.
* Liaise with SMEs (subject matter experts) in the business to ensure all design and development tasks are completed in line with applicable requirements and project timelines.
* Liaise with quality, regulatory and technical teams to assess product usability and safety throughout the design and development process, including end user usability testing as required.
* Provide support for activities falling under the remit of the Quality, Technical, Research and Regulatory Affairs teams regarding product design, development and technical documentation.
* Support internal and external audits, inspections and regulatory assessments, ensuring compliance with applicable regulations and standards.
* Where appropriate, be able to stand in for the R&D Design Assurance Manager.
Experience
* Bachelor’s Degree in a Mechanical, Engineering, life science or equivalent.
* 5 years design control or other design/research project management in a regulated environment.
* Project management skills and an ability to work to tight timelines.
* Working knowledge of ISO 13485.
* Enthusiastic and motivated to develop a career within design of Medical Devices.
* Proficient in the use of Microsoft Office.
* Excellent communication skills when liaising at all levels within the company and with external customers.
* Experience working in medical devices, pharma, automotive or aerospace manufacturing is desirable.
What do we offer?
Competitive salary and benefits!
We grow talent. At Biocomposites we create opportunities to thrive and grow.
One Biocomposites - team spirit & engagement. Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions.
People Who Are Passionate About What We Do.
People who are open minded to evolving the way we work.
People who can work together to transform outcomes and change lives.
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