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, 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.
Locations
Senior Process Engineer in Bath, Somerset employer: Kodu
As a Senior Process Engineer near Bath, you will join a dynamic engineering team dedicated to advancing molecular diagnostics that truly make a difference. With a competitive salary of £60,000–£65,000, flexible working arrangements, and opportunities for regular travel, this role offers not only a chance to lead critical projects but also to grow within a supportive environment that values data-driven decision-making and innovation. The company fosters a culture of accountability and collaboration, ensuring that your expertise is recognised and impactful.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Process Engineer in Bath, Somerset
✨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 aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by diving deep into the company’s products and processes. Show them you’re not just another candidate; you’re genuinely interested in their molecular diagnostic platform and how you can contribute to its success.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation and reiterate your enthusiasm for the role. It keeps you fresh in their minds!
✨Tip Number 4
Apply through our website! We’ve got a streamlined process that makes it easy for you to showcase your skills. Plus, it shows you’re serious about joining our team and helps us keep track of your application.
We think you need these skills to ace Senior Process Engineer in Bath, Somerset
Some tips for your application 🫡
Tailor Your CV:Make sure your CV speaks directly to the role of Senior Process Engineer. Highlight your experience with IQ, OQ, and PQ, and don’t forget to mention any data analysis skills you have. We want to see how your background fits with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Share specific examples of how you've held contract manufacturers accountable and tackled data analysis challenges. We love a good story!
Showcase Your Data Skills:Since data interrogation is key for us, make sure to highlight your experience with tools like Minitab or Power Query. Give us a glimpse into how you've used these skills in past roles to drive results. Numbers tell a story, so let yours speak!
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you get all the updates. Plus, it shows us you're keen on joining our team at StudySmarter!
How to prepare for a job interview at Kodu
✨Know Your IQ, OQ, and PQ Inside Out
Make sure you can confidently discuss your experience with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Be ready to share specific examples of how you've led these processes in previous roles, especially in a regulated environment.
✨Data Analysis is Key
Brush up on your data analysis skills, particularly with tools like Minitab or Power Query. Prepare to talk about how you've used data to identify patterns and drive improvements in production processes. Bring examples of your work that demonstrate your analytical capabilities.
✨Challenge the Status Quo
Show that you're not afraid to push back on supplier documentation and hold contract manufacturers accountable. Think of instances where you've successfully escalated issues or improved validation processes. This will highlight your leadership and assertiveness.
✨Understand the Bigger Picture
Familiarise yourself with the company's mission and the impact of their products. Be prepared to discuss how your role as a Senior Process Engineer contributes to the overall success of the team and the company’s goals, especially in relation to the molecular diagnostic platform.
