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
Senior Process Improvement Engineer in Bath, Somerset employer: Kodu
Join a forward-thinking engineering team near Bath, where your expertise as a Senior Process Improvement 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 a unique chance to grow within a supportive environment that values innovation and accountability. Enjoy competitive benefits including a bonus, pension, and healthcare, all while being part of a mission that truly makes a difference in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Process Improvement Engineer in Bath, Somerset
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work in similar roles or companies. A friendly chat can lead to insider info about job openings and even referrals.
✨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 work and how you can contribute to their 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 us you’re serious about joining our team and ready to make an impact.
We think you need these skills to ace Senior Process Improvement Engineer in Bath, Somerset
Some tips for your application 🫡
Tailor Your CV:Make sure your CV speaks directly to the job description. 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 proficiency in tools like Minitab or Power Query. Give us examples of how you've used these tools to drive improvements in past roles.
Be Specific About Your Experience:When detailing your previous roles, be specific about your CMO oversight experience. We’re looking for real examples where you held contract manufacturers accountable, so make those stories shine!
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It’s the best way for us to keep track of your application and ensure it gets the attention it deserves!
How to prepare for a job interview at Kodu
✨Know Your Data Inside Out
As a Senior Process Improvement Engineer, you'll need to demonstrate your ability to interrogate production and QC data. Before the interview, brush up on your data analysis skills using tools like Minitab or Power Query. Be ready to discuss specific examples where you've identified patterns in data that led to process improvements.
✨Showcase Your CMO Oversight Experience
It's crucial to highlight your real-world experience with contract manufacturers. Prepare to share instances where you've held suppliers accountable for validation processes. Think of specific challenges you faced and how you overcame them, as this will show your hands-on approach and problem-solving skills.
✨Familiarise Yourself with Regulatory Standards
Since the 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 IQ, OQ, and PQ processes. Review your past experiences where you wrote and executed protocols. Be ready to explain your thought process and how you pushed back on supplier documentation when necessary, showcasing your assertiveness and attention to detail.
