Design Assurance Engineer - Medical Devices - Cambridge

ZipRecruiter; Cambridge; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading medical devices company in Cambridge is seeking a Design Assurance Engineer to enhance their quality and compliance efforts. The successful candidate will engage in critical aspects of design assurance, including planning, compliance, and evaluations in a dynamic and innovative environment, offering ample training and career progression.

Benefits

Competitive salary

Hands-on training and development

Career progression opportunities

State-of-the-art facilities

Qualifications

• Experience with design assurance and quality processes.
• Understanding of ISO 14971 standards is essential.
• Competence in reviewing QMS documents.

Responsibilities

• Author and review plans for design and performance qualifications.
• Participate in Design Reviews for quality evaluation.
• Lead QMS activities across projects.

Skills

Knowledge of quality standards

Relevant industry experience

Familiarity with design history files

Job description

Job Description

Design Assurance Engineer - Medical Devices - Cambridge

We are working with a growing medical devices company in Cambridge that is looking to hire experienced design assurance and quality professionals to lead internal QMS and DHF activities across various projects.

The role of a Design Assurance Engineer offers the opportunity to work on cutting-edge medical technology alongside world-class engineers and scientists.

Your responsibilities will include authoring and reviewing plans and specifications for design, installation, operational, and performance qualifications. You will also actively participate in Design Reviews to evaluate quality and compliance according to ISO 14971 standards.

This company has a successful history of bringing innovative products to market and is seeking an engineer or scientist to strengthen their existing quality and design assurance team.

To be considered, candidates should have knowledge of quality standards in the medical device industry, relevant industry experience, and familiarity with design history files.

In return, the company offers a competitive salary and benefits package tailored to your expectations, along with excellent career progression opportunities, hands-on training, and development. They feature state-of-the-art facilities and foster a work environment conducive to growth and advancement.

Interested candidates are encouraged to apply now. A member of our team will contact you to discuss this opportunity further.

To start the recruitment process, click 'apply now'. If your skills and expertise match the requirements, we will be in touch to discuss the next steps.

Newton Colmore Consulting is a specialized recruitment agency operating within sectors such as medical devices, scientific engineering, scientific software, robotics, electronics design, new product development, human factors, regulatory affairs, quality assurance, and field service engineering across Europe and the US.

Keywords: Medical Devices, Quality Engineer, ISO 13485, QMS, Printed Circuit Board, Programmable Electrical Medical Systems, Design Assurance.