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, flexible work schedule, travel opportunities, and comprehensive benefits.
- Other info: Opportunity for career growth in a well-resourced engineering function.
- 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 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:
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Senior Process Engineer in Somerset 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 lead impactful projects in a supportive environment that values data-driven decision-making and employee growth.
