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Embedded Systems Engineer (Medical Device Expert) - Fully Remote - Up to 100,000
KO2's client, an innovative and rapidly growing start-up in the medical device sector, is seeking an Embedded Software Engineer with a strong background in medical devices to join their team. This is a unique opportunity to contribute to a cutting-edge product that is revolutionizing IVD analysis with a fully self-contained, digital solution. With an exclusive UK distribution agreement and recent funding, the business is in an exciting, healthy position, and now needs a medical device expert to take it to the next level.
The Role:
As the company's new Embedded Software Engineer, you will play a key role in driving the next phase of product development, focusing on New Product Introduction (NPI), transfer to production, and ensuring regulatory compliance. With responsibilities in project management, you'll oversee the validation plans, reports, and system implementation for clinical design whilst working hands-on, understanding the embedded C and C# tech stack and managing the technical team that powers this innovative product.
This role is ideal for someone with a passion for medical devices who is ready to lead the engineering efforts at a critical juncture in the company's growth. You'll work closely with the founding team, which has already developed the MVP and is gearing up for the product's full-scale production.
Key Responsibilities:
- Lead NPI and manage the transfer of a ground-breaking medical device into full production.
- Oversee compliance, regulatory requirements, and quality management systems (QMS) to ensure the product meets industry standards.
- Work with an ARM system and an embedded C tech stack alongside clever electronics powering the device.
- Manage technical teams and external contractors while being involved in technical requirements, ensuring smooth project delivery.
- Collaborate on the development of a UVD analysis device, including proprietary consumables and a digital analyser, to eliminate subjectivity in medical results.
Requirements:
- Proven experience as an Embedded Software Engineer in the medical device industry.
- Strong knowledge of medical device regulations and compliance, making you a true medical device expert.
- Experience with embedded C
- Ability to manage NPI, production transfer, and validation processes in a high-growth, start up environment.
- Experience in leading teams and working on embedded systems for medical applications.
What's on Offer:
- Competitive salary of up to 100,000, fully remote working. Visiting site once per month
- Opportunity to join a dynamic, founder-led start-up that is pushing the boundaries of medical device technology.
- Be part of a company with a unique, investor-backed business model and a secure future.
If you are a medical device expert and Embedded Software Engineer looking to step into a leadership role and make a tangible impact on healthcare technology, KO2's client wants to hear from you!
Apply today to be part of this exciting journey!
