Sr Manager, Process Engineering

Sr Manager, Process Engineering

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

What You Will Do:

• Own global manufacturing quality system documentation and represent Varian in internal and external audits (e.g., ISO 13485, MDSAP) as process owner for areas including Production Process Controls (PPC), Resource Management (RMT), and related procedures, ensuring consistent application across all sites
• Establish and govern document lifecycle management, including creation, revision, approval, and periodic review
• Drive global standardization of processes, resolving site-level variation and ensuring alignment to defined requirements
• Own the end-to-end engineering change management execution, ensuring changes are controlled, timely, auditable, and effective in resolving underlying issues
• Lead a multi-functional team including process engineering, change management, program management, and drafting (via a functional manager), ensuring alignment between process definition, documentation, and execution
• Establish and monitor KPIs for change management performance, including cycle time and implementation effectiveness
• Prepare and coach manufacturing engineering teams for audits, including readiness reviews and gap closure
• Drive alignment across Manufacturing, Engineering, Quality, and Supply Chain to implement systemic improvements across sites, even where direct ownership is distributed
• Drive continuous improvement of global processes, incorporating lessons learned from audits, deviations, and performance gaps
• Identify and resolve systemic issues in process execution, documentation quality, and change management effectiveness through projects and the CAPA process
• Translate manufacturing and quality performance data into prioritized, actionable improvements, ensuring alignment between process control updates, change execution, and reduction of systemic non-conformances

What You Will Have:

• Deep understanding of manufacturing quality systems, including PPC, risk management, and controlled documentation
• Expertise in engineering change management principles, configuration management, and BOM control
• Strong knowledge of ISO 13485, FDA QSR, and audit expectations for medical device manufacturers
• Proven ability to lead global, cross-functional teams and drive alignment across sites
• Strong communication and influencing skills across engineering, quality, regulatory, and operations organizations
• High discipline in documentation, traceability, and audit readiness
• Demonstrated ability to define process governance and drive standardization at scale
• Leverages AI-assisted tools (e.g., Copilot, Copilot Studio, GitHub Copilot, or other approved solutions) to drive system-level productivity, establish standardized workflows, and ensure outputs are validated, compliant, and aligned with engineering and regulatory requirements

Required Education and Experience

• Engineering or technical bachelor's degree (or equivalent experience) with 12+ years of related experience
• Significant experience in Medical Devices and experience supporting external audits (ISO 13485, MDSAP, FDA)
• Demonstrated experience owning quality system processes
• 5+ years of people leadership experience managing global or distributed teams

What Will Set You Apart:

• Advanced degree (Master's or MBA)
• Lean / Six Sigma Black Belt or equivalent certification and demonstrated implementation experience
• Experience with SAP, MES, or equivalent systems supporting change control and configuration management