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Sandoz

Leader in generic and biosimilar medicines

Device Project Lead

Biomedical Engineering & Medical DevicesUpdated on Nov 12
Full-timeCambridge, UK

About the Job

Requirements

  • A university degree in a relevant subject, such as mechanical engineering, product design, or physics, or an equivalent degree with at least five years of experience.
  • Knowledge of Good Manufacturing Practice and international device regulations.
  • Fluency in English.
  • Experience with combination products or their device constituent parts, and standalone medical devices.

Responsibilities

  • Lead project planning, coordination, specifications, risk management, documentation, and design transfer, and oversee development including detailed design, ergonomics, usability, and human factors/usability engineering documentation; lead design reviews.
  • Create and manage Design History Files and associated documentation for selected combination products in accordance with the annual plan, objectives, and relevant standards and guidance, including ISO 13485, 21 CFR Part 820.30, and 21 CFR 3.2(e).
  • Lead, represent, and manage cross-functional device project teams.
  • Manage activities in accordance with project strategies, budget, timelines, regulatory, quality, and professional standards.
  • Enable operational excellence in compliance with current and anticipated professional trends.
  • Perform activities in compliance with Good Manufacturing Practice.
  • Ensure inspection readiness.

About the Company

Sandoz

Leader in generic and biosimilar medicines

What does the company do? Sandoz is a global leader in generic and biosimilar medicines, with a broad portfolio of about 1,300 products that address diseases from the common cold to cancer. How does its product work? The medicines are off-patent (generics) or biosimilars that match the reference brands in safety, quality, and efficacy, offering affordable treatment options to patients and helping healthcare systems save money while expanding access. How is it different from competitors? Sandoz emphasizes scale, a long heritage dating back to 1886, and a sizeable global workforce dedicated to broadening patient access, aiming for large social impact and substantial healthcare savings. Its leadership in biosimilars and the breadth of its portfolio set it apart in the market. What is the company's goal? To pioneer access for patients by making high-quality medicines more affordable and widely available worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1886

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