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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 a focus on continuous improvement and career development.
- Why this job: Make a real impact in healthcare by optimising manufacturing processes for life-saving devices.
- 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 Renfrew employer: Terumo Aortic
Contact Detail:
Terumo Aortic Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Process Development Engineer in Renfrew
✨Tip Number 1
Network like a pro! Reach out to people 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 manufacturing. Use the STAR method (Situation, Task, Action, Result) to structure your answers and showcase your problem-solving skills.
✨Tip Number 3
Showcase your technical knowledge! Be ready to discuss specific tools and methodologies you've used, like Six Sigma or process validation strategies. This will demonstrate your expertise and readiness for the role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Process Development Engineer in Renfrew
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 environments and any relevant projects that showcase your skills in process validation and design for manufacturability.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about medical devices 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 past roles. We love a structured, data-driven approach, so share any specific methodologies you’ve used, like Six Sigma or PFMEA.
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 development 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 Yourself 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, as this will demonstrate your ability to maintain compliance and quality.
✨Showcase Your Problem-Solving Skills
Be ready to share specific instances where you've tackled challenges in process development or manufacturing. Use the STAR method (Situation, Task, Action, Result) to structure your answers, highlighting your structured, data-driven approach to problem-solving.
✨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-technical team members, as this will be key in collaborative environments.