Design Assurance Engineer in Keele

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 Design Assurance Engineer will be responsible for coordinating and implementing design controls for medical device changes and new product developments, aid 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.

Location & Working pattern

• Primary working location: Keele office (IC4/5). Office-based role.
• Standard working hours: Monday-Friday, 09.00-17.00 / 08.00-16.00

Duties & Responsibilities

• Maintain and manage compilation 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 Assessments, including Hazard Analysis and Risk Management, and ensure appropriate risk mitigation strategies are implemented throughout the design process and product lifecycle.
• Track design control project status, chair meetings (e.g. design reviews) and ensure actions are allocated to appropriate members of the design team.
• Coordinate and manage Biocomposites’ design control process and systems in line with ISO 13485 requirements including SOPs, Templates, Forms and Reports for Design Inputs, Design Outputs, Design Reviews, Design Transfer, Design Verification and Validation, Design History File, Device Master Record and Design Master File.
• Liaise with SMEs (subject matter experts) in the business to ensure all design and development tasks are completed in line with applicable requirements.
• Lead design teams through the design process from concept planning through to completion of design transfer to production.
• Analyse processes, design and implement product changes and improvements using data obtained through design control.
• 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.

Essential Requirements

• Bachelor’s Degree in a Mechanical, Engineering, life science or equivalent
• 3+ 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
• Exceptional project management and teamworking skills
• Enthusiastic and eager to learn, 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
• Commutable to the office and able to work (Mon-Fri, 9am-5pm/8am-4pm)

Desirable Requirements

• Medical Devices design training or ISO 13485 internal auditor qualification
• 5+ years design control or other design/research project management in a regulated environment
• Experience working in medical devices, pharma, automotive or aerospace manufacturing
• Knowledge of electronic document management systems
• Specific knowledge of ISO 13485 design control requirements
• Working knowledge of medical device regulations globally
• Ability to present and chair meetings with senior board members

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.

Who do we look for?

• 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.

Benefits:

• Company events
• Company pension
• Employee discount
• Free or subsidised travel
• Free parking
• On-site parking