Device Project Lead

Device Project Lead

Cambridge (Hybrid)

6 month contract

Inside IR35 so Umbrella engagement only

Rate £380/day 

A growing pipeline of medical device and drug/device combination projects are seeking a Device Project Lead. By successfully leading the development of the medical devices/combination products, you will help to launch commercially competitive products that will increase access for patients.

Key Accountabilities:

- in relation to combination products (or device constituent parts thereof) and standalone medical devices:

o Project leadership (planning, co-ordination, specifications, risk management, documentation, design transfer etc.); and

o Development oversight (market research; user research; concept generation, development and analysis; detail design (e.g. including 3D CAD and engineering drawings); ergonomics and usability (including HF/UE documentation); design reviews).

- creation and management of Design History Files and associated documentation for selected combination products in accordance with the annual plan and objectives, and relevant standards and guidances e.g. ISO13485, 21 CFR Part 820.30, 21 CFR 3.2(e). etc;

- lead, represent, and manage cross-functional device project teams;

- management of activities in accordance with project strategies, budget, timelines, regulatory, quality, and professional standards;

- enabling operational excellence in compliance with the current and anticipated professional trends;

- performing activities in compliance with Good Manufacturing Practice; and

- ensuring inspection readiness.

Minimum requirements:

- university degree in relevant subject (mechanical engineering, product design, physics etc.) or other equivalent degree;

- knowledge of GMP and international device regulations;

- ability to communicate and collaborate effectively in a highly international and diverse setting;

- track record of goal-driven behavior, problem solving, ability to make pragmatic decisions, readiness for new challenges; and

- fluency in English,

Desired skills:

- work experience in medical devices/combination product development;

- knowledge of regulatory/QA requirements for medical devices/combination products; and

- digital excellence and automation of documentation management.