Device Project Lead

Posted 6 Days Ago
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Cambridge, Cambridgeshire, England
In-Office
Senior level
Biotech • Pharmaceutical
The Role
Lead cross-functional device and combination-product projects through design, development, regulatory compliance, and transfer. Manage Design History Files, usability/HF activities, risk management, budgets, timelines, GMP conformity, and inspection readiness.
Summary Generated by Built In

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

Top Skills

Microsoft Project,Waterfall Project Management,Human Factors Engineering,Design History File Management,Iso 13485,21 Cfr Part 820.30,Good Manufacturing Practice (Gmp)
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The Company
HQ: Basel
17,135 Employees

What We Do

Sandoz is the global leader in generic and biosimilar medicines. ​

​Our Purpose is to pioneer access to medicines for patients globally. We are on a mission to drive innovation in the healthcare industry by freeing up resources sustainably and responsibly while continuing to address global health challenges such as antimicrobial resistance.​

We are present in more than 100 countries and our medicines serve some 500 million people every year. We have two main global businesses: Generics - divided between standard generics and complex generics - and Biosimilars.

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