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.

Are you looking for an inspiring career? You just found it.

 

 

Job Overview

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.

 

 

Job Responsibilities and Essential Duties

Design Assurance

• 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.

Risk Management

• 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.

Verification & Validation (V&V)

• Oversee development and execution of verification and validation strategies for new products and product modifications.
• Ensure V&V activities adequately demonstrate product safety, performance, reliability, and regulatory compliance.
• Review and approve protocols, reports, test strategies, and acceptance criteria.
• Ensure traceability between requirements, risk controls, and verification evidence.

Product Stewardship

• Lead product stewardship programs to ensure ongoing product quality, safety, reliability, compliance, and customer satisfaction.
• Monitor post-market product performance metrics, complaint trends, field feedback, and quality data.
• Partner with Operations to drive continuous product improvement initiatives.
• Support lifecycle management, product refreshes, obsolescence management, and end-of-life planning.
• Lead Complaint management from R&D functionality point of view.

Document Control

• Lead document control processes and governance for quality records and controlled documents.
• Ensure compliance with document management procedures and electronic quality management systems.
• Maintain oversight of controlled documentation including procedures, specifications, design documentation, protocols, reports, and labeling.
• Drive continuous improvements in documentation processes, efficiency, and compliance.

Labeling Compliance

• Ensure product labeling, Instructions for Use (IFU), artwork, promotional claims, and product identifiers comply with applicable globa