Senior Design Quality Engineer

Ensera Design is a world-class user-centred innovation and product development consultancy specializing in the medical and consumer health sectors with offices in Bristol Colorado and New Jersey. As part of Ensera we collaborate globally with contract manufacturing facilities in Europe the USA and Asia.

We are currently seeking an experienced Senior Design Quality Engineer to join our talented team and contribute to delivering exceptional solutions for our clients.

The role will be responsible for the day-to-day management oversight and continuous improvement of Quality activities. This role ensures all quality related activities are executed in compliance with applicable EU MDR EMA and FDA regulations including 21 CFR Partsinternal procedures customer requirements and all other industry applicable regulations and standards.

• 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 provide 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-submission 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 required.

About you

Youll 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. Youll 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.

Your 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 (we think someone with between 5 and 8 years of experience is likely to have the level of competence we are looking for).

• 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 ISOCFR 820 and cGMP

• Experience in Risk Management tools and techniques (ISO14971)

• Experience in IEC62304 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.

The salary for this role is in line with our Senior band from 51000 up to 73954. 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 roles scope.

Why work with us

Ensera Design offers interesting and varied work combined with a supportive team culture to provide a stimulating environment where you will have the opportunity to develop and learn from others. We offer flexible working policies where working patterns are agreed with our line managers taking into account the role needs of the individual and the team.

We recognise that we are only as good as our people and we know how important it is to support our team.

We offer:

• Performance-related company-wide bonus.

• Flexible hybrid working in line with our core hours (MonThu 9:30am12:00pm & 2:00pm4:00pm; Fri 9:30am12:00pm).

• 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 the first Monday of every month alongside our company-wide meeting.

• Free breakfast every Wednesday and plenty of opportunities to socialise including team-organized activities summer and Christmas parties and more.

About us

We are based in an iconic Grade II listed building in the heart of Bristol. Our vibrant workspace houses state-of-the-art labs a design studio usability suites and collaborative meeting spaces. Nestled in a lively neighbourhood with independent shops were just a short walk from Park Street the Harbourside and St. Nicks Markets.

We are proud of our values:

• Find a way: We work as one team combining our knowledge and experience to unite around a shared goal. We trust each other and do whats needed to get things done and exceed expectations.

• Pull together: We believe anything is possible. When faced with challenges we take the initiative using our creative spirit and determination to find bold solutions and deliver results that move us forward.

• Care: We act with integrity take pride in our work and support each other. We each play our part to make a positive impact for our customers our colleagues and our planet.

Our diverse multidisciplinary team spans research design human factors engineering prototyping manufacturing and beyond. Together we deliver cutting-edge solutions for clients ranging from global leaders to innovative start-ups with a particular focus on medical devices drug delivery orthopaedics and diagnostics.

Do we sound like a good match for you

If youd like to discuss the role or would like to discuss any reasonable adjustments you may need to make your application wed love to hear from you. If you think you might be the right person for us but want an informal chat first then get in touch via .

We plan to shortlist applications as they come in. We look forward to hearing from you!

At Ensera Design we believe that designing for people means including all people starting with the team behind the work. Our human-centred design ethos is rooted in empathy and our values pull together find a way and care guide us in building a team that reflects the diversity of the world we design for.

We know that different perspectives lead to better ideas stronger collaboration and more meaningful outcomes. If you meet the skills and experience for this role we welcome your application whatever your background identity or path into design. What matters to us is that you share our belief in purposeful people-first design.

Polite notice for agencies We appreciate the interest from recruitment partners; however we are managing this hiring process directly and ask that agencies do not contact us regarding this role. Unsolicited CVs will be considered as a gift to Ensera Design.