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- Tasks: Support the transfer of new medical devices from R&D to manufacturing, ensuring quality and compliance.
- Company: Join a leading medical device company focused on innovation and quality.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative team environment with strong focus on career development.
- Why this job: Make a real impact in healthcare by optimising manufacturing processes for life-saving products.
- Qualifications: HND in engineering and experience in regulated manufacturing environments required.
The predicted salary is between 35000 - 45000 £ per year.
We are recruiting a Process Development Engineer to support the successful transfer of new medical device products from R&D into full-scale manufacturing. This role plays a key part in ensuring design intent, quality, regulatory compliance and operational efficiency are maintained through validation and into commercial production. Working cross-functionally with R&D, Quality, Operations, Supply Chain and Regulatory teams, you will help deliver robust, repeatable and scalable manufacturing processes within a highly regulated medical device environment.
Key responsibilities
- Support product transfer from development into manufacturing, ensuring process, documentation and resource readiness
- Develop, optimise and validate manufacturing processes, work instructions and processing methods
- Support Design for Manufacturability (DfM) activities early in the product lifecycle
- Develop and execute process validation strategies in line with regulatory standards (e.g., FDA 21 CFR 820, ISO 13485)
- Define and execute equipment qualification activities
- Conduct risk management activities, including PFMEA, and drive mitigation actions
- Lead root cause analysis and corrective/preventive actions during pilot builds and early production
- Generate technical and regulatory documentation including validation protocols, reports and process specifications
- Maintain audit readiness and ensure alignment with Quality Management System requirements
- Support pilot builds, manufacturing scale-up and external supplier process development
- Carry out additional duties in support of departmental and site objectives
What we’re looking for
- Minimum of HND (or equivalent) in a relevant engineering discipline
- Experience working in a regulated manufacturing environment, ideally medical devices
- Strong understanding of process design and industrialisation
- Experience with process validation, statistical methods and Six Sigma tools
- Exposure to New Product Introduction (NPI) or design transfer activities
- Working knowledge of ISO 13485 and FDA Quality System Regulations
- Ability to develop process solutions including jigs, fixtures, tooling and equipment
- Strong problem-solving capability with a structured, data-driven approach
- Excellent communication skills and ability to work effectively in cross-functional teams
- High attention to detail with disciplined documentation practices
- Proactive, results-driven mindset with clear ownership of deliverables
Process Development Engineer in Inchinnan employer: Terumo Aortic
Contact Detail:
Terumo Aortic Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Process Development Engineer in Inchinnan
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend relevant events, and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by practising common questions related to process development and medical device manufacturing. We recommend using the STAR method (Situation, Task, Action, Result) to structure your answers and showcase your problem-solving skills.
✨Tip Number 3
Showcase your expertise! Bring along examples of your previous work, such as process validation strategies or risk management activities you've led. This will help demonstrate your hands-on experience and how you can add value to the team.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team and contributing to our mission.
We think you need these skills to ace Process Development Engineer in Inchinnan
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Process Development Engineer role. Highlight your experience in regulated manufacturing environments and any relevant projects that showcase your skills in process validation and design transfer.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about the medical device industry and how your background aligns with our needs. Don’t forget to mention your experience with cross-functional teams!
Showcase Your Problem-Solving Skills: In your application, give examples of how you've tackled challenges in previous roles. We love seeing a structured, data-driven approach to problem-solving, especially in a highly regulated environment like ours.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Terumo Aortic
✨Know Your Processes
Make sure you brush up on your knowledge of process design and validation. Be ready to discuss specific examples from your past experience where you've optimised manufacturing processes or supported product transfers. This will show that you understand the key responsibilities of the role.
✨Familiarise with Regulations
Since this role involves working in a highly regulated environment, it's crucial to be well-versed in ISO 13485 and FDA regulations. Prepare to talk about how you've navigated these standards in previous roles, and be ready to discuss any relevant documentation you've worked on.
✨Show Your Problem-Solving Skills
Be prepared to share specific instances where you've tackled challenges using a structured, data-driven approach. Highlight your experience with root cause analysis and corrective actions, as this will demonstrate your capability to handle issues effectively in a manufacturing setting.
✨Communicate Effectively
Since you'll be working cross-functionally, strong communication skills are a must. Practice articulating your thoughts clearly and concisely. Think about how you can convey complex technical information to non-engineers, as this will be key in collaborating with R&D, Quality, and other teams.