Mechanical Engineer (Medical Device, 13485, 14971, CAD) – £40k – South Wales (Hybrid Working)

My Medical Device Client are looking for a Mechanical Engineer with experience with new product introduction of mechanical electrical medical devices. This role is based in our head office in Chepstow. We are looking for an ambitious and motivated individual with a degree in mechanical engineering, electrical engineering, product design or related discipline with a strong interest and experience in medical device development to support:

• Research and implementation of software into our range of single use endoscopic equipment
• Our design and development procedure, producing design control, risk management and technical reports according to international standards and our internal procedures
• Generating full design packages, design history and risk management files to facilitate transfer to production and preparing for submission to regulatory processes

Your key responsibilities of the Mechanical Engineer (Medical Device, 13485, 14971, CAD)

• Ideate, develop and test new technologies. Be a key influencer in the direction of our product development strategy.
• Design mechanical electrical medical devices including design for manufacturing and design for assembly/ disassembly.
• Support verification and validation activities by planning, performing and documenting tests as appropriate.
• Overcome challenges and solve problems to enable fast paced progress.
• Co-ordination with internal/external stakeholders, including clinicians, contract designers and contract manufacturers.
• Communicate clearly and professionally to facilitate project management tasks.
• Adherence to a quality management system

Your skills and experience of the Mechanical Engineer (Medical Device, 13485, 14971, CAD)

• A degree in mechanical engineering, product design or related discipline
• Competent in core design methodologies and tools, design documentation and change control.
• Accountable for your own workload, while being happy to build positive collaborations with colleagues, suppliers and customers.
• Able to travel to supplier/ customer sites.
• Well organised, able to manage their own time effectively and track multiple tasks at various level of completion.
• Able to work in a fast-paced environment, willing to pick up new skills and make informed decisions based on available evidence and expertise.

Desired Skills:

• Previous experience with Solidworks CAD would be an advantage.
• Familiarity with risk management for medical devices (ISO 14971) would be an advantage.
• Experience with verification and validation of medical devices, including test method design, sample size calculations, and technical reporting would be an advantage.
• A strong interest and be able to understand the medical device field, or other highly regulated environment. Experience working in an ISO 13485 environment would be an advantage.

What’s on offer:

My client is committed to giving you opportunities to be your best. They believe in embracing the passion and potential of their people, and to achieve this they offer:

• £38,000 – £40,000 (depending on experience)
• Hybrid Working (3 days on site)
• Pension
• 25 days’ holiday plus bank holidays
• Life Assurance
• Private Healthcare
• Additional Flexible Benefits.
• Career Progression

My client wants to have offered the role to the successful candidate within weeks so if you are interested, please don’t hesitate to contact me. My client offers a 3-stage process that can be completed within 2 weeks subject to your availability.

If you are interested in this role, please apply to this role with your CV attached.