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 65000 - 85000 £ 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 Bristol 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 across Europe and the Far East, this role offers not just a job but a chance to contribute to groundbreaking technology in a supportive environment that values data-driven decision-making and employee growth.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Process Engineer in Bristol
✨Tip Number 1
Network like a pro! Reach out to your connections in the engineering field, 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 someone who understands their cartridge-based molecular diagnostic platform and can bring real value to the team.
✨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 and shows your genuine interest.
✨Tip Number 4
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 the initiative to connect directly with us.
We think you need these skills to ace Senior Process Engineer in Bristol
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your experience as a Senior Process Engineer, especially your work with IQ, OQ, and PQ. We want to see how you've led projects and held contract manufacturers accountable, so don’t hold back on those details!
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 in your previous jobs. We love seeing candidates who can pull insights from data, so make it clear how you’ve done this before.
Be Clear and Concise:When writing your application, keep it straightforward. We appreciate clarity, so avoid jargon unless it’s relevant to the role. Make sure your passion for engineering and the impact of your work shines through!
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 to join 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 IQ, OQ, and PQ processes. Be ready to share specific examples of how you've written and executed protocols, and don't shy away from discussing any challenges you faced while holding suppliers accountable.
✨Data Analysis is Key
Brush up on your data analysis skills, especially with tools like Minitab or Power Query. Prepare to talk about how you've used these tools to identify patterns in production and QC data. Having a couple of real-life examples where your analysis led to significant improvements will definitely impress.
✨Understand CMO Oversight
Be prepared to discuss your experience with contract manufacturers. Highlight instances where you've not only reviewed documentation but also challenged it when necessary. Show that you know how to hold CMOs accountable and ensure validation rigour is maintained.
✨Familiarity with Regulations is Crucial
Since this role involves working in a regulated environment, make sure you're well-versed in ISO 13485 and FDA QSR. Be ready to explain how you've applied these regulations in your previous roles, demonstrating that you understand their importance in day-to-day engineering practice.
