At a Glance
- Tasks: Lead process qualification and data analysis for innovative diagnostic products.
- Company: Dynamic engineering team focused on impactful medical technology.
- Benefits: Competitive salary, bonus, pension, healthcare, and flexible working arrangements.
- Other info: Opportunity for travel and career growth in a supportive engineering culture.
- Why this job: Join a pioneering team making a difference in healthcare with cutting-edge diagnostics.
- 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.
The Senior Process Engineer owns process qualification, data analysis, and CMO oversight on a cartridge-based molecular diagnostic platform shipping at commercial scale.
- 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.
- Support cost-down and reliability projects, including reagent redesign, polymer substitutions, and supplier changes.
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.
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.
Locations
Process / Senior Process Engineer in Bath, Somerset employer: Kodu
Join a pioneering engineering team near Bath, where your expertise as a Senior Process Engineer will directly contribute to the development of groundbreaking molecular diagnostic products. With a strong focus on data analysis and process qualification, you'll enjoy a flexible work environment that promotes employee growth and collaboration, alongside competitive benefits including a bonus, pension, and healthcare. This is an opportunity to be part of a mission-driven company that values evidence-based decision-making and offers a supportive culture for innovation.
StudySmarter Expert Advice🤫
We think this is how you could land Process / 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 or even a referral.
✨Tip Number 2
Prepare for interviews by diving deep into the company’s products and processes. Show us you know your stuff about IQ, OQ, and PQ, and how they apply to cartridge-based diagnostics. We love candidates who can discuss data analysis and CMO oversight with confidence!
✨Tip Number 3
Don’t just wait for job postings; be proactive! Check our website regularly for new opportunities and consider reaching out directly to hiring managers. A little initiative can go a long way in landing that Senior Process Engineer role.
✨Tip Number 4
Practice your storytelling skills. When you get the chance to interview, share specific examples of how you've tackled challenges in previous roles, especially around data interrogation and supplier accountability. We want to hear how you’ve made an impact!
We think you need these skills to ace Process / Senior Process Engineer in Bath, Somerset
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 previous 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’re looking for evidence of your ability to pull insights from production and QC data, so don’t hold back!
Demonstrate CMO Oversight Experience:We need someone who can hold contract manufacturers accountable. Share your experiences where you’ve done this effectively, focusing on validation and not just paperwork. Real-world examples will make your application stand out!
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 don’t miss any important updates. Plus, we love seeing candidates who take that extra step!
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 pulled insights from data to drive decisions.
✨Showcase Your CMO Oversight Experience
It's crucial to highlight your real-world experience in holding contract manufacturers accountable. Prepare to share instances where you've successfully managed IQ, OQ, and PQ processes, and how you’ve pushed back on supplier documentation when necessary. This will show that you understand the importance of accountability in the role.
✨Familiarise Yourself with Regulatory Standards
Since this role involves working within a regulated environment, make sure you're well-versed in ISO 13485 and FDA QSR. Be prepared to discuss how you've applied these standards in your previous roles, not just in theory but in practical, day-to-day engineering practices.
✨Prepare for Technical Discussions
Expect to engage in technical discussions about process qualification and change control. Brush up on your knowledge of SPC, DOE, and capability studies. Think of scenarios where you've led projects related to cost-down initiatives or reliability improvements, as these will be key talking points during your interview.
