Medical Device Expert

Medical Device Expert – Fully Remote – Up to £100,000

Please read the information in this job post thoroughly to understand exactly what is expected of potential candidates.

KO2's client, a dynamic and innovative start-up in the medical device sector, is seeking a Medical Device Expert to join their growing team. With a revolutionary IVD analysis device and bespoke consumables, the company is in an exciting phase, preparing for full production after successfully developing their MVP. As a Medical Device Expert, you will play a pivotal role in driving the business forward, overseeing project management, compliance, and technical integration.

The Role:

As the Medical Device Expert, you will lead the transfer of the product into production, ensuring compliance with regulatory and quality standards. You’ll be responsible for the validation plans, reports, and the implementation of design systems. Working closely with a small, talented team, this is a 75% project management role with the remaining 25% requiring technical knowledge in technical software.

KO2's client is investor-funded, in a healthy financial position following a recent round of funding, and holds an exclusive distribution agreement in the UK. The product, an IVD analysis system that removes subjectivity in diagnostics through image processing, is ready for production, and the Medical Device Expert will be critical to this transition.

Key Responsibilities:

• Lead NPI and manage the transfer of a cutting-edge medical device into production.
• Oversee compliance, regulatory requirements, and QMS to ensure product quality and adherence to medical standards.
• Collaborate with internal and external teams on the ARM system, embedded firmware, and cloud integration with AWS.
• Manage the technical team and ensure smooth project delivery while staying involved in technical aspects like embedded systems and software.
• Work closely with the founding team to drive the company's vision forward and help scale the business.

Requirements:

• Extensive experience as a Medical Device Expert, with in-depth knowledge of regulatory and compliance standards in the medical device sector.
• Solid understanding of embedded C and C# with experience in project management and technical team leadership.
• Experience in the NPI process, taking medical products from development to full production.
• Ability to navigate start-up environments and be hands-on in both technical and managerial capacities.

What’s on Offer:

• Competitive salary of up to £100,000, fully remote working.
• The opportunity to work for a founder-led, high-growth company in a niche medical device market.
• Be part of an exciting journey in a company with a strong financial footing and significant potential for growth.

If you are a Medical Device Expert ready to take on a leadership role and make a real impact in the healthcare technology sector, KO2's client wants to hear from you! Apply today to be part of this innovative and fast-growing company.