Development Manager – Medical Device Development
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 Development 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 work-streams.
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
- 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
- Experience with complex diagnostic/therapeutic devices
- Experience managing US FDA regulatory interactions or GLP/GMP study programmes
- 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
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