At a Glance
- Tasks: Lead hands-on process qualification and data analysis for innovative medical devices.
- Company: Dynamic engineering team focused on impactful molecular diagnostics.
- Benefits: Competitive salary, flexible work, travel opportunities, and healthcare benefits.
- Other info: Exciting career growth in a well-resourced environment with a supportive leadership.
- Why this job: Join a pioneering team making a difference in healthcare with cutting-edge technology.
- Qualifications: Experience in process engineering and knowledge of injection-moulded components required.
The predicted salary is between 60000 - 65000 £ per year.
Tens of thousands of injection-moulded cartridges ship every month, and the engineering team needs someone hands-on enough to own the process qualification and interrogate the data.
Scope of the Role
- The Senior Process Engineer works hands-on across process qualification, CMO oversight, and data analysis on a cartridge-based molecular diagnostic platform shipping at commercial scale. You are on the floor as much as at your desk.
- Lead IQ, OQ, and PQ across two contract manufacturers and the on-site pilot line, hands-on.
- Pull and interrogate production and QC data to surface patterns, not just headlines.
- Work directly with SolidWorks models to understand and influence component geometry on cost-down and reliability changes.
- Own change control and impact assessments with quality, regulatory, and engineering.
- Review and challenge CMO documentation on injection-moulded components, escalating where validation rigour falls short.
Key Skills and Experience Required
- Extensive hands-on experience as a Senior Process Engineer, Process Engineer, or Manufacturing Engineer in a regulated medical device or IVD environment.
- Direct experience with injection-moulded components or polymer disposables, including knowledge of how tooling decisions affect process performance.
- Proven ownership of IQ, OQ, and PQ end to end, including writing protocols and holding CMOs accountable on validation documentation.
- Working proficiency in SolidWorks alongside strong data analysis capability using Minitab, Power Query, or equivalent, with working knowledge of SPC and DOE.
- 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 a working pilot line, rich production data, and a Director of Engineering who appreciates someone who gets on the floor and argues from evidence. Engineering decisions still move the business here.
How to Apply
Want to find out more? Click apply, and we’ll be in touch.
Locations
Senior Mechanical Engineer in Bath, Somerset employer: Kodu
Join a forward-thinking engineering team in Trowbridge, where your expertise as a Senior Mechanical Engineer will directly impact the production of groundbreaking molecular diagnostic products. With a strong emphasis on hands-on involvement, flexible working arrangements, and opportunities for travel, this role offers a collaborative work culture that values evidence-based decision-making and fosters professional growth. Enjoy competitive salary packages, bonuses, and comprehensive healthcare benefits while contributing to a mission that truly matters.
