Senior Design Assurance Engineer

2 weeks ago

Maldon, United Kingdom Cure Talent Ltd Full time
Cure Talent is delighted to partner with a well established Medical Device Manufacturer based in Essex. This innovative company specialises in the design and development of a wide array of orthopaedic products. Due to their continued exceptional growth, we are seeking a Senior Design Assurance Engineer to join their dynamic team.
The successful candidate will have the opportunity to apply their skills and engineering knowledge in areas such as quality systems, supplier controls, design assurance, test method development and validation, design controls, and regulatory affairs for a wide range of innovative medical device projects.
Key day-to-day responsibilities include:
* Leading key development activities within multidisciplinary device design teams, focusing on user needs, design input, and risk management (ISO 14971).
* Creating and reviewing design documentation, ensuring its suitability for inclusion in Design History/Technical Files.
* Contributing expertise to Design Verification/Validation activities, ensuring compliance and efficacy in the product development process.
We are looking for the following experience, skills, and qualifications:
* Bachelor's degree in a relevant scientific or engineering discipline.
* Proven experience and a thorough understanding of MDR and ISO 13485.
* Experience working under medical device design controls, with proven knowledge of design verification/validation and design/process FMEAs.
* Knowledge and demonstrated practice of risk management methodologies as per ISO 14971.
If you're seeking an exciting opportunity to be part of a rapidly expanding company at the forefront of health technology innovation, get in touch today

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