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- Tasks: Lead quality management for innovative medical device projects and ensure compliance with industry regulations.
- Company: Ensera Design, a global leader in user-centred innovation for health sectors.
- Benefits: Flexible hybrid working, private healthcare, generous leave, and performance bonuses.
- Other info: Embrace a culture of empathy and collaboration in a dynamic work environment.
- Why this job: Join a diverse team making a real impact in the medical device industry.
- Qualifications: Senior-level experience in quality assurance within medical devices or pharmaceuticals.
The predicted salary is between 51000 - 73954 £ per year.
Ensera Design is a world‑class user‑centred innovation and product development consultancy, specialising 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.
Responsibilities
- Partner with electromechanical and software engineering and design teams to deliver new products to market in compliance with required quality requirements and processes.
- Guide project teams through consistent, compliant and lean delivery according to Design Control and Risk Management processes.
- Provide clear updates to stakeholders across the business and guidance on project readiness.
- Develop and 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.
- Interface with external regulatory experts and clients to drive collaborative delivery of Design History Files.
- Support continual improvement of Quality System processes and tools that support the product development process.
- Provide coaching and training to other teams relating to Design Control processes and continuous improvement.
- Support our quality and delivery teams with carrying out QMS and project audits when required including participation as a subject matter expert.
About you
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.
Your skills and experience
- 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 (5‑8 years of experience is typical).
- 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 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.
Salary and Benefits
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.
- Performance‑related company‑wide bonus.
- Flexible hybrid working in line with our core hours (Mon–Thu, 9:30am–12:00pm & 2:00pm–4:00pm; Fri, 9:30am–12:00pm).
- 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.
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.
Senior Design Quality Engineer in Bristol employer: HS Design, Inc.
Contact Detail:
HS Design, Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Design Quality Engineer in Bristol
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device sector and let them know you're on the lookout for opportunities. A friendly chat can lead to insider info about openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU MDR, FDA regulations, and quality management systems. We want you to be able to showcase your expertise confidently and demonstrate how you can contribute to Ensera's mission.
✨Tip Number 3
Don’t just wait for job postings; proactively reach out to companies you admire, like Ensera. Express your interest in their work and ask if they have any upcoming roles that might suit your skills. You never know what could come from a simple email!
✨Tip Number 4
When you get an interview, make sure to prepare some thoughtful questions about their design processes and team dynamics. This shows you're genuinely interested in how you can fit into their culture and contribute to their projects.
We think you need these skills to ace Senior Design Quality Engineer in Bristol
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Design Quality Engineer role. Highlight your experience in quality management and compliance with regulations like MDR and ISO 13485. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality engineering in the medical device sector. Share specific examples of how you've led teams or improved processes, so we can see your impact.
Showcase Your Communication Skills: Since this role involves interfacing with various stakeholders, it's crucial to demonstrate your communication skills. Whether it's in your CV, cover letter, or any additional documents, make sure to highlight your ability to convey complex information clearly.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us. Plus, it’s super easy!
How to prepare for a job interview at HS Design, Inc.
✨Know Your Regulations
Make sure you brush up on the relevant regulations like EU MDR, FDA guidelines, and ISO standards. Being able to discuss these confidently will show that you understand the compliance landscape and can navigate it effectively.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully managed quality activities in a regulated environment. Highlight your experience with medical devices or pharmaceuticals, as this will resonate well with the interviewers.
✨Collaborative Mindset
Since the role involves working closely with various teams, be ready to discuss how you've collaborated with engineers and designers in the past. Share instances where your input led to successful project outcomes, demonstrating your ability to work in a team.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to quality management and product development. This not only shows your interest in the role but also gives you a chance to assess if the company aligns with your values and career goals.