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The Global MSAT & Engineering function is undergoing a strategic modernization initiative to introduce innovative, efficient, and sustainable manufacturing technologies across our global device manufacturing footprint. As the Group Lead for Device Process Engineering, you will be the architect of our technical talent and process excellence. This is a dual-impact leadership role: you will serve as a senior technical authority for our most complex device programs and lead a world-class chapter of Process Engineers, ensuring they have the skills, tools, and standardized methodologies to deliver next-generation medical devices and drug-device combination products to patients worldwide.
Lead, coach, and develop a high-performing team of process engineers, setting clear expectations for technical excellence and functional capability.
Define and drive the global process-engineering strategy for device and combination product assembly, packaging, and sterilization across the entire product lifecycle.
Act as the senior technical authority for complex engineering decisions, balancing quality, compliance, supply, and speed-to-market.
Drive structured process characterization using DOE and statistical tools to define operating windows and ensure process understanding.
Establish methodologies for identifying critical process parameters (CPPs) and material attributes to ensure robust control strategies.
Own design transfer activities, translating design outputs into production specifications, equipment requirements, and manufacturing work instructions.
Define and govern risk-based validation strategies for manufacturing processes, equipment qualification, and sterilization.
Manage the process-engineering framework for continued process verification, investigation support, and lifecycle optimization.
Ensure all engineering practices comply with global regulatory requirements, including FDA QMSR, ISO 13485, and EU MDR.
You are a strategic and technically credible leader who moves fluently between executive decision-making and deep engineering problem-solving. You have the ability to explain complex validation decisions to diverse audiences, translating technical risks into clear business impacts. You are a dedicated coach and talent developer who sets high standards for technical rigor while empowering your team to act. As an effective communicator and resilient collaborator, you build trust across matrixed organizations and remain focused on shared objectives even during periods of ambiguity or change.
Further you have the following qualifications and experiences:
Degree (B.S., M.S., or Ph.D.) in Mechanical Engineering, Pharmaceutical Engineering, or a related technical field.
12-15+ years of experience in process engineering or technical operations within regulated medical device or pharma environments.
Proven track record in formal people leadership and influencing across a matrixed global organization.
Deep expertise in device assembly, packaging, sterilization, and automated manufacturing from development to commercial scale.
Strong knowledge of design controls, risk management (ISO 14971), DfM, and technical transfer processes.
Experience working with global external manufacturing partners and supplier networks.
Are you ready to make a difference for our patients? We are looking forward to your application – join us now and become part of our journey!
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.