Senior Validation Engineer (MedTech)

TL;DR

Senior Validation Engineer (MedTech): Leading and executing validation activities for equipment, processes, and systems in a high-volume manufacturing environment with an accent on New Product Introduction (NPI) and regulatory compliance. Focus on designing and executing IQ/OQ/PQ strategies, managing design transfer, and mitigating technical risks to ensure successful product launches.

Location: Onsite Lausanne, Vaud, Switzerland

Salary: 111,200 - 166,800 CHF

Company

A global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life through engineering and innovation.

What you will do

• Lead validation activities during New Product Introduction (NPI) and technology transfer to manufacturing.
• Define and execute process validation strategies (IQ/OQ/PQ) aligned with regulatory requirements.
• Partner with R&D to ensure Design for Manufacturability (DfM) and validation readiness.
• Conduct risk management activities, including FMEA and process capability studies.
• Lead investigations for validation-related deviations, CAPAs, and change controls.
• Oversee pilot builds and engineering runs for high-volume production ramp-up.

Requirements

• Bachelor’s or Master’s degree in engineering or a related field.
• 7+ years of experience in validation, manufacturing engineering, or quality within a regulated industry.
• Proven expertise in lifecycle management (IQ/OQ/PQ).
• Experience in MedTech or pharmaceutical manufacturing.
• Strong understanding of GMP and ISO 13485 standards.

Culture & Benefits

• Competitive salary and flexible benefits package.
• Environment focused on exploration, innovation, and healthcare equity.
• Opportunity to work within a global team of passionate engineers.