At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

Responsibilities may include the following and other duties may be assigned:

• Lead validation activities during New Product Introduction (NPI) and technology transfer to manufacturing
• Define own and execute process validation strategies aligned with product process and regulatory requirements
• Act as the validation subject-matter expert during design transfer phases
• Partner with R&D to ensure Design for Manufacturability (DfM) and validation readiness early in development
• Review product designs specifications and manufacturing processes to ensure robustness and compliance
• Lead the development and execution of validation deliverables including:
• o Process validation (IQ/OQ/PQ)
• o Equipment and system qualification
• o Test method validation (where applicable)
• Ensure effective and compliant design transfer through:
• o Risk management activities (e.g. FMEA)
• o Process characterization and capability studies
• o Complete audit-ready documentation aligned with regulatory expectations
• Support and lead pilot builds engineering runs and ramp-up to high-volume production
• Proactively identify assess and mitigate technical and validation risks to ensure successful product launches
• Serve as the validation technical authority for manufacturing operations
• Lead investigations for validation-related deviations CAPAs and change controls
• Ensure processes and systems remain in a validated state throughout their lifecycle
• Support continuous improvement initiatives while maintaining compliance

Required Knowledge and Experience:

• Bachelors or masters degree in engineering or related field (e.g. HEIG-VD HES-SO or equivalent)
• 7 years of experience in validation manufacturing engineering or quality in a regulated industry
• Strong experience with lifecycle management (IQ/OQ/PQ)
• Experience in MedTech or pharmaceutical manufacturing
• Exposure to automated or high-volume production environments
• Solid understanding of GMP ISO 13485 and regulatory expectations

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.

Learn more about our business mission and our commitment to diversity here