R&D Manager

GxPeople Global; Greater London; On-site; GBP 90,000 - 130,000; Full time

Benefits offered by this job

Equity

Benefits

Office-based in UK with travel

Job summary

GxPeople Global partners with a venture-backed UK medical device company to recruit an experienced R&D Manager for its London-based development programme. The role combines technical ownership across hardware, software and system-level workstreams with leadership of design transfer and regulatory readiness as the team scales ahead of clearance and launch.

You will chair reviews, manage the Design History File, coordinate across engineering, clinical affairs, regulatory, quality and supply chain,

Qualifications

• Degree in engineering, life sciences, or a related technical discipline.
• 5+ years in medical device development in hands-on engineering or development management role.
• Experience taking Class II/III devices through development, design transfer and regulatory submission.
• Direct experience of design transfer: process validation and manufacturing documentation.
• Strong understanding of ISO 13485, design controls and FDA 510(k) or CE-mark submission processes.
• Excellent problem-solving instincts and root-cause analysis capability.
• Proven ability to plan with MS Project, Smartsheet, Jira, or equivalent tool.
• Clear, confident communicator with ability to translate technical complexity for stakeholders.
• Self-starter who thrives in a lean, fast-moving startup environment.

Responsibilities

• Take technical ownership of the development programme across hardware, software, and system-level workstreams.
• Lead structured problem-solving on blockers—root-cause investigation, design trade-offs, testing strategy.
• Chair technical and design reviews; maintain clear status reporting to leadership.
• Own the Design History File aligned to regulatory submission schedule.
• Lead design transfer into manufacture: process validation and manufacturing documentation.
• Coordinate across engineering, clinical, regulatory, quality and supply chain teams.
• Manage third-party development partners and contract suppliers; control the programme budget.

Skills

R&D leadership

Medical device

ISO 13485

Regulatory submission

Design transfer

Project management

Problem solving

Communication

Lean startup

Education

Engineering degree

Life sciences degree

Tools

MS Project

Smartsheet

Jira

Job description

R&D 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 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