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.
- Other info: Opportunity for travel and career growth in a supportive environment.
- Why this job: Join a pioneering team making a difference in molecular diagnostics.
- Qualifications: Extensive experience in regulated environments and strong data analysis skills.
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.
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
Senior Processing Engineer in Bath, Somerset employer: Kodu
Join a forward-thinking 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 emphasis on data-driven decision-making, flexible working arrangements, and opportunities for regular travel, this role offers not only competitive compensation but also a supportive work culture that prioritises employee growth and innovation in a meaningful field.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Processing 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 data analysis techniques. Brush up on Minitab and Power Query, and be ready to discuss how you've used these tools to drive process improvements in your previous roles.
✨Tip Number 3
Showcase your experience with IQ/OQ/PQ during interviews. Be specific about how you've owned these processes and held contract manufacturers accountable. Real-life examples will make you stand out!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Senior Processing 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/PQ and any relevant data analysis skills. We want to see how your background aligns with our needs!
Showcase Your Data Skills:Since data interrogation is key for this role, don’t hold back on showcasing your data analysis capabilities. Mention specific tools like Minitab or Power Query that you’ve used, and give examples of how you've pulled insights from production data.
Be Clear About Your Experience:When detailing your past roles, be clear about your ownership of processes and your experience with contract manufacturers. We’re looking for someone who can hold suppliers accountable, so share any relevant stories that demonstrate this.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
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. Brush up on your data analysis skills using tools like Minitab or Power Query, and be ready to discuss specific examples where you've identified patterns or insights from data.
✨Showcase Your CMO Oversight Experience
Make sure to highlight your real-world experience in holding contract manufacturers accountable. Prepare to discuss how you've managed IQ, OQ, and PQ processes, and be ready to provide examples of how you've pushed back on supplier documentation when necessary.
✨Understand Regulatory Standards
Familiarise yourself with ISO 13485 and FDA QSR regulations as they relate to your day-to-day engineering practice. Be prepared to talk about how you've applied these standards in previous roles, especially in a regulated medical device or IVD environment.
✨Be Ready for Technical Discussions
Since the Director of Engineering values evidence-based arguments, come prepared with technical knowledge and examples that showcase your problem-solving skills. Think about cost-down projects or reliability improvements you've led, and how you approached them with data-driven decisions.
