At a Glance
- Tasks: Lead process qualification and data analysis for a cutting-edge diagnostic platform.
- Company: Innovative medical device company near Bath with a focus on impactful engineering.
- Benefits: Competitive salary, flexible work schedule, travel opportunities, and comprehensive healthcare.
- Other info: Dynamic role with excellent career growth and a supportive engineering culture.
- Why this job: Join a pioneering team making a real difference in healthcare technology.
- Qualifications: Extensive experience in regulated environments and strong data analysis skills required.
The predicted salary is between 60000 - 65000 £ per year.
Production is running at tens of thousands of cartridges a month. The cartridge engineering team needs someone who can interrogate that data properly.
Scope of the Role
- The Senior Process Engineer owns process qualification, data analysis, and CMO oversight on a cartridge-based molecular diagnostic platform shipping at commercial scale. This is not a support seat. You lead the work.
- Lead IQ, OQ, and PQ across two contract manufacturers and the on-site pilot line.
- Pull and interrogate production and QC data to surface patterns, not just headlines.
- Own change control and impact assessments with quality, regulatory, and engineering.
- Review and challenge CMO documentation, escalating where validation rigour falls short.
- Support cost-down and reliability projects including reagent redesign, polymer substitutions, and supplier changes.
Key Skills and Experience Required
- Extensive experience as a Senior Process Engineer, Process Engineer, Manufacturing Engineer, or Validation Engineer in a regulated medical device or IVD environment.
- Proven ownership of IQ, OQ, and PQ, including writing and executing protocols and pushing back on supplier documentation.
- Real CMO oversight experience, holding contract manufacturers accountable on validation, not just reviewing the paperwork they send.
- Strong data analysis capability using Minitab, Power Query, or equivalent, with working knowledge of SPC, DOE, and capability studies.
- Solid grounding in ISO 13485 or FDA QSR in day-to-day engineering practice, not just certification knowledge.
Salary and Benefits
- £60,000 - £65,000.
- Three days on site per week, with flexibility around data-heavy periods.
- Regular travel to European contract manufacturers, with the option to join Far East visits.
- Bonus, pension, and healthcare (details to be confirmed at offer stage).
This is an engineering team working on something that matters. The product is a molecular point-of-care diagnostic, the first of its kind to receive FDA clearance in its category, now shipping at volume after a $65m funding round. The Senior Process Engineer joining now steps into a properly resourced function with rich production data and a Director of Engineering who is technical enough to appreciate someone who argues from evidence. Engineering decisions still move the business here.
How to Apply
Want to find out more? Click apply and we'll be in touch.
Senior Process Engineer in Bath employer: Kodu
Join a forward-thinking engineering team near Bath, where your expertise as a Senior Process Engineer will directly impact the production of groundbreaking molecular diagnostics. With a flexible work schedule, opportunities for travel, and a culture that values data-driven decision-making, you'll thrive in an environment that prioritises innovation and employee growth. Enjoy competitive salary packages, bonuses, and comprehensive healthcare benefits while contributing to a product that truly makes a difference.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Process Engineer in Bath
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work in medical devices or IVD environments. A friendly chat can lead to insider info about job openings that might not even be advertised yet.
✨Tip Number 2
Prepare for interviews by diving deep into the company’s products and processes. Understand their cartridge-based molecular diagnostic platform inside out. This shows you’re genuinely interested and ready to lead the work right from day one.
✨Tip Number 3
Showcase your data analysis skills! Bring examples of how you've interrogated production and QC data in past roles. Use real-life scenarios to demonstrate your ability to surface patterns and drive improvements.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets the attention it deserves. Plus, we love seeing candidates who take that extra step to connect with us directly.
We think you need these skills to ace Senior Process Engineer in Bath
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your experience with IQ, OQ, and PQ processes. We want to see how you've owned these in past roles, especially in regulated environments. Don’t just list your duties; show us the impact you made!
Show Off Your Data Skills:Since data analysis is key for this role, include specific examples of how you've used tools like Minitab or Power Query. We love seeing how you've pulled insights from production data to drive improvements.
Be Clear on CMO Oversight:We need someone who can hold contract manufacturers accountable. In your application, share instances where you've challenged documentation or ensured validation rigour. This will show us you're not just a paper reviewer!
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to keep track of your application and get back to you quickly. We’re excited to hear from you!
How to prepare for a job interview at Kodu
✨Know Your Data Inside Out
As a Senior Process Engineer, you'll need to demonstrate your ability to interrogate production and QC data. Before the interview, brush up on your data analysis skills, especially with tools like Minitab or Power Query. Be ready to discuss specific examples where you've identified patterns in data and how that influenced your decision-making.
✨Showcase Your CMO Oversight Experience
This role requires real oversight of contract manufacturers, so be prepared to share your experiences in holding CMOs accountable. Think of instances where you challenged supplier documentation or improved validation processes. Highlight your proactive approach and how it led to better outcomes.
✨Demonstrate Your Knowledge of IQ/OQ/PQ
Since you'll own IQ, OQ, and PQ processes, it's crucial to articulate your experience clearly. Prepare to discuss specific protocols you've written and executed. If you can provide examples of how you've pushed back on supplier documentation, that will show your depth of understanding and assertiveness in quality control.
✨Familiarise Yourself with Regulatory Standards
Having a solid grounding in ISO 13485 or FDA QSR is essential for this position. Make sure you can speak confidently about how these standards have influenced your day-to-day engineering practices. Bring up any relevant projects where compliance was key, and how you navigated challenges related to regulatory requirements.
