R&D Design Assurance Manager

Job Description

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 R&D Design Assurance Manager will be part of the research and development team and will support strategic product development projects being undertaken at Biocomposites.  You will also be responsible for the whole design process related to current and future R&D projects, in order to achieve business objectives effectively. At the same time providing technical expertise and solutions to facilitate product development and eventual transfer to commercial production.

Responsibilities:                                                                               

• Take overall responsibility for design projects from concept to transfer into commercialisation, ensuring projects are delivered on time and within budget.
• Manage the creation, development and maintenance of all relevant design dossiers (design history files) and related technical documentation.
• Manage the design review process, ensuring all activities are completed in line with project timelines.
• Manage the design change process, ensuring that all changes are reviewed and implemented appropriately.
• Evaluate design concepts and assess technical challenges and project-associated risks.
• Plan and co-ordinate the activities of the design team, ensuring compliance to procedures and regulatory requirements is maintained.
• Collaborate with internal and external stakeholders to optimize design activities.
• Ensure that design activities and requirements are communicated and understood by relevant stakeholders.
• Provide design engineering support for equipment, process and product validation.
• Lead and mentor the design assurance team.
• Monitor technological advances and identify opportunities to upskill the design team.
• Develop and implement test procedures with necessary technical, quality and regulatory input.
• Provide subject matter expert input for internal and external audits, inspections and regulatory assessments.

Reruired experience:

• Level 5 in appropriate Engineering / Design discipline. 
• Minimum 5 year experience in Pharma or Medical Device
• Demonstrable knowledge of the design process associated with product development from concept to commercial release.
• Strong leadership attributes, problem solving, desire to improve through change.

What do we offer?

Competitive salary and benefits! With us, you will receive a competitive salary package 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, life assurance, employee assistance programme
• Employee discount
• Free or subsidised travel
• Free on-site parking