[Hiring] Senior Design Assurance Engineer @1006 United Kingdom
Mar 21, 2025 - 1006 United Kingdom is hiring a remote Senior Design Assurance Engineer. 💸 Salary: unspecified. 📍Location: UK.
Role Description
As a Senior Design Assurance Engineer, you will drive the subject matter expertise of our Design Control process, as well as our Risk Management process and participate in improvement of our processes, support the product documentation during all phases of NPD projects and review essential parts of the technical documentation.
- Driving adherence to the design control as well as risk management processes in product development projects.
- A key figure in the planning and follow-up of all design control activities.
- Involved in all project activities, through review and approval to ensure compliance to our standard operating procedures and instructions as well as external standards and regulations.
- Involved in assessing, developing, and continuously improving the standard operating procedures, instructions, and templates, in the context of risk management and product development.
Qualifications
- Master’s or bachelor’s degree in engineering, pharmacy, technical science, or similar technical diploma in laboratory science.
- Proven 5 years experiences as Design Assurance Engineer or similar.
- Proven experience with maintenance and development of QMS processes or design control processes within new product development in Medical Device context.
- Hands-on experience with Design Control in accordance with EU ISO 13485, US 21CFR820, ISO 14971 and MDR.
- Experience with requirements engineering, product risk management, and usability engineering.
- Knowledge within regulatory legislation and standards.
- Preferable knowledge within Medical Device product development (Class II).
Requirements
- Extensive experience from a similar role as Design Control Engineer or Product Quality Engineer, in new product development or in remediation.
- Ability to cooperate and build strong collaboration with other functions, like Global Quality, R&D, RA, Process Engineering and Production.
- Strong communication skills to achieve a common goal and deliver high quality and timely solutions and deliverables.
- Appreciation for thoroughness and correctness as a natural focus of daily work.
- Ability to drive and follow up on the cross-functional team’s contributions to the design control documentation.
- Skill in prioritizing tasks to meet agreed project timelines and adherence to the process.
Benefits
- Opportunity to work in a dynamic environment.
- Support to bring your ideas to life.
- Challenges that will help you grow and make a significant impact.
Travel Requirements
- Up to 10 travel days per year, primarily to manufacturing sites in Reynosa (MX), Deeside (UK), and Osted (DK).
Languages
- Speaking: English
- Writing/Reading: English
- Danish and Spanish is nice to have.
Working Conditions
This role may be based in the United Kingdom with a remote working structure - office presence will be required or allowed for certain meetings, events, or to meet certain business needs.
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| 📍 | Be aware of the location restriction for this remote position: UK |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
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Salary
💸
unspecified
|
Remote
Location
UK
|
|
Job Type
full-time
|
Posted
Mar 21, 2025
|
| 📍 | Be aware of the location restriction for this remote position: UK |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
