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 schedule, travel opportunities, and healthcare benefits.
- Other info: Opportunity for 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, especially with injection-moulded components and regulatory standards.
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.
- 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.
Senior Mechanical Engineer employer: Kodu
Kodu is an exceptional employer that fosters innovation and creativity in the field of robotic prosthetics. With a strong emphasis on employee growth, you will have the opportunity to take ownership of significant projects while enjoying a flexible hybrid working environment in Leeds. The collaborative work culture encourages direct access to technical leadership, making it a rewarding place for passionate engineers to thrive.
