Design Engineer
South Wales
Yolk Recruitment is partnered with an innovative medical device business during an exciting period of expansion and has a new opportunity for a Product Design Engineer to join a collaborative R&D team in a role offering variety and involvement in all aspects of developing life-changing products.
The business has dominated its market in the UK for decades and following successful entry into new international markets and significant capital investment has created opportunities for Design Engineers who can truly develop products from concept to delivery to play a key role in their continued commitment to innovation.
This is a varied role requiring analytical and practical technical ability, the ability to solve engineering problems, and capacity for original thinking. You'll benefit from ongoing professional and career development opportunities in a secure and growing business, annual pay increases, and regular personal pay reviews. This would well suit a Design Engineer with a background in medical, electromechanical systems, and device development.
This is what you'll be doing as Design Engineer:
1. Deliver NPD project from discovery to product launch.
2. Preparing the technical file and design history file for regulatory submission.
3. Support for regulatory affairs and quality activities to ensure products meet regulations and registration.
4. Lead and support NCR and CAPA.
5. Knowledge of statistical analysis is essential.
6. Lead and support QMS maintenance with R&D Manager.
The experience you'll bring to the team in this Design Engineer role:
1. HND, Degree or equivalent experience in mechanical, electromechanical or medical engineering.
2. Knowledge of statistical analysis is essential.
3. Good knowledge and have completed projects with key standards such as ISO13485, IEC60601, and 21CFR820, completing a technical file.
4. Knowledge on development of user requirements and specifications with clinicians, biocompatibility, packaging testing, materials and characterisation methods, statistical analysis and developing verification and validation plans and testing.
5. Ability to use AutoDesk Inventor would be advantageous.
And this is what you'll get in return:
1. Salary in line with experience.
2. 25 days holiday + bank holidays.
3. Company pension.
4. Annual performance-related pay review.
5. Training and Career Development Opportunities.
6. State of the art premises, free parking.
7. Funded social events.
8. Restaurant and Gym discounts.
If you believe that you have the skills and experience for this Product Design Engineer role - apply now.
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