At a Glance
- Tasks: Support innovative medical device projects from concept to commercial manufacture.
- Company: Rapidly growing medical device company with a collaborative engineering culture.
- Benefits: Competitive contract rate and significant involvement in product development.
- Other info: Join a dynamic team focused on continuous improvement and innovation.
- Why this job: Make a real impact in the medical field while working on cutting-edge technology.
- Qualifications: Experience in quality engineering within the medical device industry is essential.
The predicted salary is between 30000 - 40000 £ per year.
An exciting opportunity has arisen for an experienced Quality Engineer to join a rapidly growing medical device company based in Hertford. This is not a traditional Quality Systems or CAPA-focused role. Instead, we are seeking an engineering-led Quality professional who understands the complete product lifecycle, from concept and design through to manufacturing, testing, validation, and production release.
Working closely with R&D, Manufacturing Engineering, Operations, and Regulatory Affairs teams, you will play a key role in bringing innovative medical devices from development into successful commercial manufacture. The role requires a strong understanding of design transfer, manufacturing processes, product testing, inspection methodologies, validation activities, and production quality assurance.
The successful candidate will be equally comfortable:
- Reviewing engineering drawings and specifications
- Developing manufacturing documentation
- Validating production processes
- Supporting new product introductions within a regulated medical device environment
Key Responsibilities:
- Support New Product Development (NPD) projects from concept through to commercial manufacture.
- Work closely with Design, R&D, and Manufacturing Engineering teams throughout the product development lifecycle.
- Participate in design reviews and provide input regarding manufacturability, testability, reliability, and product quality.
- Support Design Transfer activities, ensuring products are successfully transitioned from development into production.
- Review engineering drawings, specifications, BOMs, manufacturing instructions, and product requirements.
- Ensure manufacturing and quality requirements are incorporated into product designs from an early stage.
- Assist in developing production processes capable of consistently delivering compliant products at scale.
Manufacturing Engineering & Production Support:
- Support manufacturing readiness activities for new product launches.
- Develop and implement inspection methods, quality plans, test protocols, and manufacturing procedures.
- Create manufacturing and quality documentation from scratch where required.
- Work with production teams to optimise assembly and manufacturing processes.
- Support Design for Manufacture (DFM) and Design for Assembly (DFA) initiatives.
- Drive continuous improvement activities focused on process capability, product quality, and manufacturing efficiency.
Testing, Inspection & Product Verification:
- Develop and execute product testing strategies for new and existing products.
- Establish incoming, in-process, and final inspection methodologies.
- Perform and oversee product inspections against engineering specifications and acceptance criteria.
- Support verification and validation testing activities.
- Analyse test data and provide recommendations for product or process improvements.
- Ensure robust traceability and documentation throughout manufacturing operations.
- Review and approve production records and manufacturing documentation as part of batch release activities.
- Support equipment qualification and manufacturing process development.
- Participate in risk assessments, PFMEA activities, and process capability studies.
- Ensure manufacturing processes are capable, repeatable, and suitable for production scale-up.
- Act as the quality and manufacturing interface between Engineering, Operations, Regulatory Affairs, and Supply Chain teams.
- Support technical investigations relating to product performance and manufacturing processes.
- Collaborate with Regulatory Affairs to ensure product and manufacturing compliance requirements are met.
- Contribute to technical decision-making throughout product development and manufacturing phases.
Qualifications:
- Previous experience as a Quality Engineer, NPI Engineer, Manufacturing Engineer, Product Quality Engineer, or similar role within the medical device industry.
- Experience supporting products through the full lifecycle from design and development through to manufacturing and commercial release.
- Experience working with design transfer activities within regulated manufacturing environments.
- Strong understanding of medical device assembly and manufacturing processes.
- Experience developing manufacturing procedures, work instructions, inspection plans, and test methods.
- Experience with incoming, in-process, and final inspection activities.
- Hands-on experience with product testing, validation, and verification activities.
- Ability to interpret engineering drawings, specifications, tolerances, and technical documentation.
- Strong understanding of Design for Manufacture (DFM) and Design for Assembly (DFA) principles.
- Engineering-focused mindset with strong technical curiosity.
- Strong attention to detail and commitment to product quality.
- Self-motivated with the ability to manage multiple projects and priorities.
Opportunity to join an innovative and growing medical device business with significant involvement in product development, manufacturing scale-up, and new product launches. Collaborative engineering-led culture. Competitive contract rate.
If you have a strong engineering background within medical devices and enjoy working at the intersection of product development, manufacturing, testing, and quality, we would love to hear from you.
Graduate Engineer / Quality Engineer employer: Maclivaro Limited
Join a rapidly growing medical device company in Hertford, where you will be part of a collaborative engineering-led culture that values innovation and quality. With significant involvement in product development and manufacturing scale-up, this role offers competitive contract rates and ample opportunities for professional growth in a dynamic environment focused on bringing cutting-edge medical devices to market.
StudySmarter Expert Advice🤫
We think this is how you could land Graduate Engineer / Quality Engineer
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device industry on LinkedIn or at local meetups. We can’t stress enough how valuable personal connections can be in landing that Quality Engineer role.
✨Tip Number 2
Prepare for interviews by brushing up on your technical knowledge and understanding of the product lifecycle. We recommend practising common interview questions related to design transfer and manufacturing processes to show you’re the right fit.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and interests. We suggest checking out our website for opportunities that excite you, especially in innovative medical device firms.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We believe showing appreciation for the opportunity can set you apart from other candidates.
We think you need these skills to ace Graduate Engineer / Quality Engineer
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Engineer role. Highlight your experience with product lifecycle, design transfer, and manufacturing processes. We want to see how your skills align with what we're looking for!
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 your past experiences that relate to the job description.
Showcase Your Technical Skills:Don’t forget to showcase your technical skills in your application. Mention your hands-on experience with inspection methodologies, validation activities, and any relevant software tools you’ve used. We love a candidate who knows their stuff!
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates. Plus, it’s super easy!
How to prepare for a job interview at Maclivaro Limited
✨Know Your Product Lifecycle
Make sure you understand the complete product lifecycle, especially in the context of medical devices. Brush up on your knowledge of design transfer, manufacturing processes, and validation activities, as these will likely come up during the interview.
✨Familiarise Yourself with Regulatory Standards
Since this role involves working within a regulated environment, it’s crucial to be well-versed in relevant regulations and standards. Research the specific compliance requirements for medical devices and be prepared to discuss how you've navigated these in past roles.
✨Prepare for Technical Questions
Expect to answer technical questions related to engineering drawings, inspection methodologies, and quality assurance processes. Review your previous experiences and be ready to provide examples that showcase your problem-solving skills and technical expertise.
✨Show Your Collaborative Spirit
This role requires close collaboration with various teams, so be prepared to discuss how you’ve successfully worked with R&D, manufacturing, and regulatory affairs in the past. Highlight any experiences where teamwork led to successful product launches or improvements in quality.
