Device Project Lead

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, coordination, 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).
• 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.

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.

Skills Desired

• Adaptive Strategy And Innovation
• Clinical Research
• Cross-Functional Teams
• Drug Development
• Financial Management
• Interpersonal Communication SkillsMicrosoft 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

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