Device Project Lead

Sandoz; Cambridge; Hybrid; GBP 70,000 - 100,000; Full time

Benefits offered by this job

Annual bonus

Pension scheme

Health insurance

24 days leave

Job summary

Sandoz is seeking a senior device project leader in the Cambridge area to drive development of combination products and medical devices. You will oversee planning, risk management, design transfer, and regulatory documentation while coordinating cross-functional teams across borders.

The role requires a degree in a relevant field, 5+ years of experience, GMP knowledge, and fluency in English. A flexible, hybrid work arrangement and a competitive benefits package are offered.

Qualifications

• University degree in relevant subject and 5+ years of experience.
• Knowledge of GMP and international device regulations.
• Ability to communicate and collaborate in a highly international setting.
• Track record of goal-driven behavior and problem solving.

Responsibilities

• Lead projects for combination products and devices, including risk management and design transfer.
• Manage cross-functional device project teams and oversee budgets and timelines.
• Create and manage Design History Files per ISO13485 and applicable regulations.
• Ensure GMP compliance and inspection readiness.
• Foster operational excellence and adherence to professional standards.
• Communicate effectively across diverse, international teams.

Skills

Fluency in English

Communication skills

Cross-functional collaboration

Problem solving

Education

University degree in mechanical engineering / product design / physics

Tools

Microsoft Project

Job description

Job Description Summary

Join us, the future is ours to shape!

Job Description

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Experience with combination products (or device constituent parts thereof) and standalone medical devices

• Project leadership (planning, co-ordination, specifications, risk management, documentation, design transfer etc.); and Development oversight including ; detail design ; ergonomics and usability (including HF/UE documentation); lead 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

• Ensuring inspection readiness.

What you’ll bring to the role:

Essential Requirements:

• University degree in relevant subject (mechanical engineering, product design, physics etc.) or other equivalent degree with 5+ years of experience

• 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

• Fluency in English

You’ll receive:

• Competitive salary
• Annual bonus
• Pension scheme
• Health insurance
• 24 days annual leave
• Flexible working arrangements
• Employee recognition scheme
• learning and development opportunities.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!

Join us!

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

#Sandoz

Skills Desired

Adaptive Strategy And Innovation, Clinical Research, Cross-Functional Teams, Drug Development, Financial Management, Interpersonal Communication Skills, Microsoft Project, Npd (New Product Development), Pmi (Project Management Institute), Pmp (Project Management Professional), Program Management, Project Delivery, Project Execution, Project Life Cycle, Project Planning, R&D (Research And Development), Resource Allocation, Risk Management, Senior Management, Stakeholder Management, Time Management Skills, Waterfall Project Management