We are currently seeking an experienced Senior Design Quality Engineer to join our talented team and contribute to delivering exceptional solutions for our clients.
Responsibilities
- You will partner with electromechanical and software engineering and design teams to deliver new products to market in compliance with required quality requirements and processes.
- You will guide project teams through consistent, compliant and lean delivery according to Design Control and Risk Management processes.
- You will provide clear updates to stakeholders across the business and give guidance on project readiness.
- You will develop, maintain complete and compliant Design History Files and support the development of regulatory submissions for new products including pre‑submissions, 510(k) and other product required regulatory submissions.
- You will interface with external regulatory experts and clients to drive collaborative delivery of Design History Files.
- You will support the continual improvement of Quality System processes and tools that support the product development process.
- You will provide coaching and training to other teams relating to Design Control processes and continuous improvement.
- You will support our quality and delivery teams with carrying out QMS and project audits when required, including participation as a subject‑matter expert when needed.
About you
You will be working already at a senior level either in Consultancy, or industry, or at a start‑up within the medical device and medicinal products sector. You will be comfortable taking the lead in large project teams in complex medical device development, ready to collaborate with Software, Electronic and Mechanical Engineers, Designers, and Manufacturing experts.
Skills and experience
Whilst you do not need to meet all of these points, please ensure you meet the majority of them before making an application:
- Either a degree in a relevant engineering, design or science discipline (or equivalent qualification – advanced degree preferred), or equivalent work experience.
- Demonstrable experience of progressive quality and hands‑on experience in a regulated environment, supporting medical devices or pharmaceuticals operations (generally 5–8 years of experience).
- Experience guiding teams through compliant development of medical software and complex electromechanical systems.
- Experience in interfacing with multiple internal and external stakeholders and driving high quality work to meet their needs.
- Experience contributing to the development of Quality Management Systems and the ability to interpret regulations.
- Experience ensuring a high level of compliance with MDR, ISO 13485, 21 CFR 820, and cGMP.
- Experience with Risk Management tools and techniques (ISO 14971).
- Experience in IEC 62304 and IEC 60601 would be desirable.
- Experience in auditing to ISO 13485 would be desirable.
- Able to review and understand hardware, firmware and software requirements and specifications.
- Excellent communication and interpersonal skills.
- Excellent presentation skills, including written and verbal communication skills.
Salary
The salary for this role is in line with our Senior band, from £51,000 up to £73,954. Please note we ask you to provide your expected salary within the band as part of your application, this helps us understand how you view your experience against the role's scope.
Benefits
- Performance‑related company‑wide bonus.
- Flexible hybrid working in line with our core hours (Mon‑Thu, 9:30 am‑12:00 pm & 2:00 pm‑4:00 pm; Fri, 9:30 am‑12:00 pm).
- Private healthcare for you and your family.
- Enhanced maternity and paternity leave.
- Salary‑exchange pension scheme.
- 25 days of annual leave, plus the option to purchase up to one working week and additional days for length of service.
- Access to our Employee Assistance Programme and digital wellbeing platform.
- Cycle‑to‑Work & Electric Vehicle Lease schemes.
- Death in service (x4 gross salary).
- Training and development opportunities, including dedicated learning days and regular knowledge‑sharing sessions.
- A free lunch on the first Monday of every month alongside our company‑wide meeting.
- Free breakfast every Wednesday, and plenty of opportunities to socialise, including team‑organised activities, summer and Christmas parties, and more.
If you would like to discuss the role or request reasonable adjustments, please email careers_uk@enseradesign.com.
#J-18808-Ljbffr