Mechanical Design Engineer

Hampshire

Permanent

£competitive

We are currently looking or a Mechanical Design Engineer for a multi-award-winning manufacturer of some of the worlds most advanced prosthetic technology. This is a permanent role with a competitive salary dependent on experience.

The Role

You will be responsible for developing complex CAD geometry, concurrently performing or overseeing digital simulations. You will also be expected to collaborate with key stakeholders in the business, including some external strategic partners, and be driven to bring products to market with uncompromised quality. Other responsibilities include:

• Engage in the continuous improvement of existing products through the change management process, using root cause analysis, tolerance analysis and design trade studies to support our manufacturing partners and address post-market surveillance feedback in a timely fashion.
• Generate and evaluate detail engineering CAD geometry, demonstrating accurate design intents, simulating dynamic motion, limits/fits and accurately define methods of manufacture.
• Use digital analysis tools such as CFD and FEA to assist in effective material selection, demonstrating an appreciation for stress, fatigue, cost and thermal effects to ensure performance of products meets or exceeds performance requirements.
• Liaise with Systems engineering and clinical partners to generate solutions which meet existing requirements, executing work packages inside our product verification and validation procedures.
• Work closely with our Electronics engineering team to effectively package PCBs in IP-rated housings.
• Able to produce fully representative engineering drawings (BS 8888) with complimentary GD&T and tolerance analysis techniques.
• Maintain risk management documentation, (ISO 14971) collaborating at design and project review meetings, comfortable presenting technical data, with recommended actions.
• Produce and maintain technical documentation, in accordance with ISO 13485, FDA and an understanding of the MDR requirements.

The Person

• Demonstrable experience in the design of high-volume plastic/polymer based parts, specifically using Injection Moulding, Additive manufacturing and other near net shape applications, including understanding tool design.
• Experience of operating in a safety critical or highly regulated industry, developing Technical files, Change management documentation and V&V activities. (ISO 13485 and FDA disciplines).
• Solution orientated with the ability to deliver technical excellence and be comfortable operating in a fast-paced matrix organisation.
• Mechanical or biomedical engineering qualification and proven experience in designing, developing and implementing innovative design schemes using Solidworks or an alternative MCAD software package.