At a Glance
- Tasks: Support the transfer of innovative medical devices from R&D to manufacturing.
- Company: Globally recognised medical device organisation with a collaborative culture.
- Benefits: Gain experience in a regulated environment and develop your skills.
- Other info: Dynamic environment with opportunities for skill development and career growth.
- Why this job: Make a real difference to patients while working on cutting-edge products.
- Qualifications: Experience in regulated manufacturing and strong problem-solving skills.
The predicted salary is between 28000 - 38000 £ per year.
We are seeking an Associate Process Development Engineer to support the transfer of innovative medical device products from R&D into full-scale manufacturing. You will play a key role in ensuring that design intent, quality, regulatory compliance, and operational efficiency are maintained as products move into commercial production. This is an excellent opportunity to join a collaborative manufacturing environment and contribute to the successful delivery of new product introductions within a regulated setting.
Key Responsibilities
- Support the transfer of new products from development into manufacturing, ensuring readiness of processes, documentation and resources.
- Support the development and optimisation of manufacturing processes and work instructions.
- Contribute to Design for Manufacturability (DfM) activities early in the product lifecycle.
- Assist with development and execution of process validation strategies in line with regulatory standards.
- Support equipment qualification activities and ensure manufacturing capability meets requirements.
- Participate in risk analysis activities (e.g. PFMEA) and support mitigation actions.
- Support corrective and preventive actions during pilot builds and early production.
- Generate technical documentation including process specifications, validation protocols and reports.
- Collaborate with Quality Engineering to ensure compliance with QMS requirements.
- Work cross-functionally with R&D, Quality, Operations, Supply Chain and Regulatory teams.
- Support pilot builds and manufacturing scale-up activities.
- Partner with suppliers and external manufacturers where required.
About You
- Experience in a regulated manufacturing environment (ideally medical devices).
- Strong understanding of process design and manufacturing engineering principles.
- Knowledge of process validation, statistical methods and continuous improvement tools.
- Strong technical problem-solving capability.
- Excellent communication and stakeholder management skills.
- High attention to detail and disciplined approach to documentation.
- Ability to work effectively within cross-functional teams.
Desirable
- Experience supporting new product introduction (NPI) or design transfer.
- Knowledge of ISO 13485 and FDA quality requirements.
- Familiarity with ERP systems or digital manufacturing tools.
- Exposure to Six Sigma or structured continuous improvement methodologies.
Why Join Us
- Be part of a globally recognised medical device organisation.
- Work on innovative products that make a real difference to patients.
- Collaborate with cross-functional teams in a supportive and dynamic environment.
- Develop your skills within a structured, highly regulated manufacturing setting.
Associate Process Development Engineer in Renfrew employer: Terumo Aortic
Join a globally recognised medical device organisation where you will play a pivotal role in the transfer of innovative products from R&D to full-scale manufacturing. Our collaborative work culture fosters professional growth and development, allowing you to enhance your skills in a highly regulated environment while making a meaningful impact on patient care.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Process Development Engineer in Renfrew
✨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 Associate Process Development Engineer role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of process validation and regulatory standards. We recommend practising common interview questions related to DfM and quality compliance to show you’re ready to hit the ground running.
✨Tip Number 3
Showcase your problem-solving skills! During interviews, share specific examples of how you've tackled challenges in previous roles. We love hearing about your hands-on experience with process optimisation and cross-functional collaboration.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining our team and contributing to innovative medical device solutions.
We think you need these skills to ace Associate Process Development Engineer in Renfrew
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Associate Process Development Engineer role. Highlight your experience in regulated manufacturing environments and any relevant skills that match the job description. We want to see how you can contribute to our innovative medical device products!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about the role and how your background aligns with our needs. Don’t forget to mention your experience with process validation and cross-functional teamwork – we love collaboration!
Showcase Your Problem-Solving Skills:In your application, be sure to highlight specific examples of how you've tackled technical challenges in the past. We’re looking for strong problem-solving capabilities, so share those moments where you made a difference in process optimisation or risk analysis.
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 at StudySmarter!
How to prepare for a job interview at Terumo Aortic
✨Know Your Stuff
Make sure you brush up on your knowledge of process design and manufacturing engineering principles. Familiarise yourself with the specific requirements of the medical device industry, especially around regulatory compliance and quality standards like ISO 13485 and FDA regulations.
✨Showcase Your Problem-Solving Skills
Be ready to discuss examples of how you've tackled technical challenges in the past. Think about situations where you contributed to process validation or optimisation, and be prepared to explain your thought process and the outcomes.
✨Communicate Effectively
Since this role involves working cross-functionally, practice articulating your ideas clearly. Prepare to discuss how you've collaborated with teams like R&D, Quality, and Operations in previous roles, highlighting your stakeholder management skills.
✨Prepare for Technical Questions
Expect questions related to Design for Manufacturability (DfM) and risk analysis activities like PFMEA. Brush up on these concepts and think of relevant experiences where you applied them, as this will demonstrate your readiness for the role.
