Join our cutting-edge diagnostics engineering team and drive the development of world-class medical technology. If you’re passionate about product design, compliance, and bringing ideas to life, this is the role for you!

Senior Product Engineer
Manchester, M13 9XX

Full time, permanent
Up to £65,000 per annum

Please Note: Applicants must be authorised to work in the UK

Genedrive Diagnostics is at the forefront of medical diagnostics, developing innovative solutions to revolutionise patient care. We specialise in advanced molecular diagnostic technologies, ensuring high-performance, reliable, and accessible healthcare solutions worldwide. As part of our dynamic engineering team, you’ll be instrumental in designing, developing, and launching cutting-edge medical devices.

The Role

As a Senior/Principal Electronics & Product Engineer, you will take a leading role in the development and release of the Genedrive system. Working closely with cross-functional teams, you’ll drive innovation, ensuring compliance, functionality, and manufacturability of our next-generation diagnostic devices.

Key Responsibilities:

Act as a lead engineer for a IVD electronics products
Lead design of our instrumentation, from concept, through manufacturing up to registration with the regulator
Lead compliance approvals for FCC, EMC, CE, UKCA, CB Scheme, FDA
Conduct hardware verification, validation, and root cause analysis
Support software teams with hardware integration
Collaborate with suppliers and partners to ensure high-quality product development
Drive research and development for hardware, consumable design, and ancillary equipment/software
Manage full product lifecycle maintenance and improvement
Support manufacturing and technical service functions
Prepare and maintain technical documentation, work instructions, and operating procedures

Benefits

We offer a competitive salary, along with a supportive and collaborative work environment where your expertise will shape the future of diagnostics technology. Additional benefits include:

Career Growth – Progression opportunities within a pioneering medical tech company
Healthcare & wellbeing - Applicable cover from day one under our private healthcare policy
Innovative Projects – Work on industry-changing products
Supportive Team Culture – Be part of a team that values collaboration and innovation

The Ideal Candidate

You’re a self-driven, experienced engineer who thrives in an innovative environment. You have a strong background in product design and development, particularly in medical or highly regulated industries. About you:

5+ years' experience in end-to-end product design, from concept to manufacturing
Strong knowledge of electronic design for compliance & regulatory approvals
Expertise in IVD/medical device compliance (EU & USA)
Experience in regulated product development (ISO 13485, IVDR, 60601, EMC standards, FDA approvals) is desirable
Hands-on experience with microprocessor-controlled electronics & embedded software
Proficiency in Altium or similar schematic capture tools
Experience in optoelectronics, PID temperature control, and reliability testing
Ability to lead projects and manage multiple workstreams
Strong communication & problem-solving skills
Background in small company environment is desirable

If you’re ready to make a real impact, apply today!

How to apply for the role:

If you have the skills and experience required for this position, click “apply” today and check your inbox for an email providing more information on how to tailor your application and provide a cover letter or any supporting documents.

You must be authorised to work in the UK. No agencies please.

Closing Date: 19th March 2025

Other suitable skills and experience include Electronics Engineer, Systems Engineer, Hardware Engineer, Product Development Engineer, Medical Device Engineer, Embedded Systems Engineer, Compliance Engineer, Electrical Engineer, R&D Engineer, Mechatronics Engineer.