Sr. Manager, R&D Product Excellence

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career?

You just found it.

The Senior Manager, R&D Product Excellence is responsible for leading a multidisciplinary team responsible for Design Assurance, Risk Management, Verification & Validation (V&V), Product Stewardship, Document Control, Labeling, Compliance, CAPA, and Complaint Management activities across the product lifecycle. This role ensures that products are developed, maintained, and commercialized in compliance with applicable global regulatory requirements and quality standards while supporting business objectives, patient safety, product quality, and continuous improvement.

The position provides strategic and operational leadership for quality and compliance activities throughout new product development, sustaining engineering, post-market surveillance, and lifecycle management. The Senior Manager partners closely with Quality, Regulatory Affairs, Operations, Manufacturing, Supply Chain, Clinical Affairs, and Commercial teams to ensure robust quality systems and effective execution of Design Control requirements.

• Lead Design Assurance activities throughout the product lifecycle, ensuring compliance with Design Control regulations and quality system requirements.
• Provide quality leadership and oversight for new product development, sustaining engineering, and product lifecycle management projects.
• Ensure design inputs, outputs, verification, validation, and design transfer activities comply with applicable regulatory requirements.
• Participate in design reviews and provide independent quality oversight of development projects.
• Ensure Design History Files (DHF), Technical Files are complete, compliant, and inspection-ready.

• Lead implementation and maintenance of product risk management processes in accordance with ISO 14971.
• Ensure risk analyses are performed, maintained, and updated throughout product development and post-market activities.
• Facilitate risk assessments for design changes, field actions, CAPAs, complaints, supplier issues, and manufacturing changes.
• Ensure linkage and traceability between hazards, risks, mitigations, verification evidence, and post-market surveillance data.
• Ensure robust root cause investigations utilizing structured problem-solving methodologies.