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 teams
Experience 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 14971
Additional Information
* Occasional international travel
* Training available in medical device standards
* Opportunity to progress into a leadership position
This 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.