Senior Validation Engineer – 12 months contract

Medtronic seeks a Senior Validation Engineer for a 12-month full-time onsite role in Lausanne, CH. The position involves leading validation efforts for manufacturing processes and systems, ensuring compliance with regulatory standards like ISO 13485 and GMP, and supporting new product launches in a high-volume environment.

The Senior Validation Engineer leads validation activities for equipment, processes, and systems in a high-volume manufacturing setting. The role ensures ongoing compliance with regulatory and quality standards while supporting operational excellence. A key responsibility is providing technical leadership during New Product Introduction (NPI) and ensuring smooth, compliant design transfer into manufacturing.

Responsibilities

• Lead validation efforts during New Product Introduction (NPI) and technology transfer to manufacturing
• Develop and manage process validation strategies that align with product, process, and regulatory needs
• Act as the go-to expert for validation during design transfer phases
• Collaborate with R&D to integrate Design for Manufacturability (DfM) and ensure validation readiness early in development
• Assess product designs, specifications, and manufacturing processes for robustness and compliance
• Oversee creation and execution of validation deliverables, including IQ/OQ/PQ, equipment/system qualification, and test method validation where needed
• Maintain compliance and robustness in design transfer through risk management (e.g., FMEA), process characterization, and capability studies, supported by complete, audit-ready documentation
• Support pilot builds, engineering runs, and ramp-up to high-volume production
• Proactively identify, evaluate, and reduce technical and validation risks to ensure successful product launches
• Serve as the technical authority for validation in manufacturing operations
• Lead investigations into validation-related deviations, CAPAs, and change controls
• Maintain validated status of processes and systems throughout their lifecycle
• Support continuous improvement efforts while preserving compliance

Requirements

• Bachelor’s or master’s degree in engineering or a related field (e.g., HEIG-VD, HES-SO, or equivalent)
• 7+ years of experience in validation, manufacturing engineering, or quality within a regulated industry
• Proven experience with lifecycle validation (IQ/OQ/PQ)
• Experience in MedTech or pharmaceutical manufacturing
• Familiarity with automated or high-volume production environments
• Strong understanding of GMP, ISO 13485, and regulatory expectations

What the company offers

• Medtronic provides a competitive salary and flexible benefits package
• Access to a broad range of benefits, resources, and compensation plans tailored to support employees at different career and life stages

About the company

Medtronic is a global leader in healthcare technology, focused on solving complex health challenges. The company’s mission is to alleviate pain, restore health, and extend life. As an engineering-driven organization, it emphasizes innovation, creation, and continuous improvement, valuing diverse perspectives and engineering excellence.

• Committed to solving the most challenging health problems through innovation
• Mission-driven to alleviate pain, restore health, and extend life
• Engineering-focused culture that values experimentation, creation, and improvement
• Appreciates diverse perspectives and fosters talent in engineering excellence