Mechanical Engineer - IVD Medical Devices
Location: Runcorn (Hybrid)
Salary: £50,000
KO2's client is an established medical device business specialising in IVD systems used in the diagnosis of respiratory illnesses. They are looking to appoint a Mechanical Engineer to support the ongoing development and introduction of new diagnostic products within a regulated environment.
This position offers the opportunity to work across the full product lifecycle - from concept and development through to validation, release, and ongoing engineering improvements.
The Role
You will take ownership of mechanical development activities across new product introduction and design updates, ensuring delivery to agreed timelines, cost targets and quality standards. Working closely with cross-functional teams, you will contribute to the evolution of complex diagnostic technology.
Key Responsibilities
Lead mechanical design tasks for new and existing IVD products
Support design changes, risk reduction and continuous improvement activities
Contribute to technical decision-making and product roadmap planning
Develop and execute verification and validation testing
Record, interpret and communicate test data clearly and accurately
Ensure laboratory equipment is maintained and calibrated
Work in line with medical device quality systems and regulatory standards
Collaborate with suppliers and international engineering teamsExperience Required
Degree qualified in Mechanical Engineering (or similar)
At least 2 years' industry experience
Background in regulated or laboratory-based environments
Confident managing multiple tasks independently
Strong written and verbal communication skills
Able to commute to Runcorn (hybrid model)Desirable
5+ years' experience in industry
Exposure to gas systems or fluid handling
Experience testing medical or diagnostic devices
Familiarity with ISO 13485, ISO 60601 and ISO 14971Additional Information
Occasional international travel
Training available in medical device standards
Opportunity to progress into a leadership positionThis is a strong opportunity for a Mechanical Engineer seeking hands-on involvement in the development of innovative respiratory diagnostic technology within a collaborative and quality-focused environment