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.
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.
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 Engineer / Senior Process 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 analysis and process qualification, you'll enjoy a flexible work environment that promotes professional 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 innovation in the medical device sector.
StudySmarter Expert Advice🤫
We think this is how you could land Process Engineer / 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 data analysis techniques. Brush up on Minitab and SPC, and be ready to discuss how you've used these tools to drive process improvements. Show them you can interrogate data like a detective!
✨Tip Number 3
Don’t just wait for job postings; take the initiative! Visit our website and apply directly. Sometimes, being proactive can put you ahead of the competition and show your genuine interest in the role.
✨Tip Number 4
Be ready to showcase your experience with IQ/OQ/PQ processes. Prepare examples of how you've held contract manufacturers accountable and navigated change control. This will demonstrate your hands-on expertise and make you stand out.
We think you need these skills to ace Process Engineer / Senior Process Engineer in Bath, Somerset
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored 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 shy away from showcasing your data analysis capabilities. Mention specific tools like Minitab or Power Query that you’ve used to surface patterns in production data.
Be Clear on CMO Oversight:We’re looking for someone who can hold contract manufacturers accountable. In your application, provide examples of how you've managed CMO oversight and ensured compliance with validation processes.
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It’s the best way for us to receive your application and get you into our system quickly!
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 experience with data analysis tools like Minitab or Power Query. Be ready to discuss specific examples where you've identified patterns in data that led to significant improvements.
✨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 your potential employer that you can take charge of the validation process.
✨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 discuss how these standards have influenced your previous work and how you ensure compliance in your projects. This knowledge will set you apart as a candidate who understands the importance of quality in a regulated environment.
✨Be Ready for Technical Discussions
Given the technical nature of the role, expect in-depth discussions about engineering decisions and processes. Prepare to argue from evidence, showcasing your analytical skills and decision-making process. Think of examples where your engineering decisions had a tangible impact on production efficiency or product reliability.
