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 Parts 820, 210, 211, internal 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.

You’ll 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’ll 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.

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, ISO 13485, 21 CFR 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 £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.

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, we’re just a short walk from Park Street, the Harbourside, and St. Nick’s Markets.

We are proud of our values: