London (Office-based) | Full-time, Permanent | Competitive salary, DOE + Equity + Benefits
About the Opportunity
A venture-backed UK medical device company is developing a next-generation diagnostic platform addressing a significant unmet clinical need. Having completed a first-in-human study and with regulatory submission on the horizon, the business is scaling its team ahead of clearance and commercial launch.
They're looking for an experienced, hands-on R&D Manager to take technical and delivery ownership of their core device development programme -a high-visibility, engineering-led role sitting at the centre of engineering, clinical, regulatory, and supply chain workstreams.
Key Responsibilities
* Take technical ownership of the development programme, owning the Integrated Development Plan (IDP) across hardware, software, and system-level workstreams
* Lead structured problem-solving on technical blockers — root-cause investigation, design trade-off analysis, and testing strategy
* Chair technical and design reviews, and maintain clear status reporting to leadership
* Own the Design History File (DHF) — content and timeline — aligned to the regulatory submission schedule
* Lead design transfer into manufacture: process validation, manufacturing documentation, and resolution of design-for-manufacture and yield issues with a contract manufacturer
* Act as the central coordination point across engineering, clinical affairs, regulatory, quality, and supply chain
* Manage third-party development partners and contract suppliers
* Own the development programme budget and cost forecasting
Person Specification
Essential
* Degree in engineering, life sciences, or a related technical discipline
* 5+ years in medical device development, the majority in a hands-on engineering, R&D, or development management capacity — not a purely programme/PMO role
* Demonstrable track record taking Class II/III devices through development, design transfer, and regulatory submission, including at least one product transferred into validated production
* Direct, evidenced experience of design transfer: process validation, manufacturing documentation, and resolution of design-for-manufacture and yield issues
* Strong understanding of ISO 13485, design controls, and FDA 510(k) or CE-mark submission processes
* Strong technical problem-solving instincts, comfortable driving a failure investigation to root cause
* Sound planning discipline (MS Project, Smartsheet, Jira, or equivalent)
* Clear, confident communicator, able to translate technical complexity for non-technical stakeholders
* Self-starter, comfortable in a lean, fast-moving startup environment
Desirable
1. Experience with catheter-based or similarly complex diagnostic/therapeutic devices
2. Experience managing US FDA regulatory interactions or GLP/GMP study programmes
3. Prior experience in a Series A–B medical device company
What's on Offer
* A pivotal, high-impact role in a well-funded, commercially focused medical device company
* Competitive salary, equity participation, and benefits
* Office-based in the UK with periodic international travel
* The opportunity to help shape both the product and the organisation as it scales
Salary description
£80000.00 - £100000.00 per year