Product Safety and Risk Manager

Job Title

Product Safety & Risk Manager (Software Systems Engineering)

Job Description

The Product Risk Manager ( with a Software Systems Engineering View) is responsible for overseeing cross-functional teams in risk management activities during product development, ensuring compliance with regulations and standards, managing multiple products, guiding direct reports, conducting inquiries into incidents, driving process improvements, acting as a liaison between departments, and improving risk communication strategies internally and externally. The role orchestrates highly complex process improvement initiatives within workstreams and drives efficiency and innovation through strategic insights and collaborative efforts. The role acts as a key liaison between risk management and departments including quality assurance, R&D, and medical affairs/medical safety and ensures seamless coordination and integration of product safety risk considerations across various functions. The role manages initiatives to improve both internal and external risk communication strategies with stakeholders and customers, and actively engages in industry conferences, forums, and working groups to remain updated on evolving best practices and emerging trends in product risk management.

Roles and Responsibilities

• Oversees the product development cross-functional team responsible for developing all risk management deliverables for one or more products throughout its' lifecycle.
• Reviews post- market product risk assessments to ensure ongoing product safety and compliance, participates in teams developing mitigations for potential hazards or issues that may arise, and facilitates risk mitigation strategies to uphold product integrity and safeguard patient, user, and consumer safety.
• Provides advanced business-level guidance on product hazards and harms and collaborates with medical affairs to ensure identification of harms and alignment with applicable regulations and standards, aiming to mitigate risks and safeguard product integrity and patient, user and consumer safety.
• Owns multiple products, requiring efficient management and coordination across various teams and stakeholders to ensure comprehensive risk management strategies are implemented effectively throughout each product's lifecycle.
• Analyzes key performance indicators (KPIs) pertaining to product risk management processes, facilitating informed decision-making and strategic planning within the department to ensure optimal performance and compliance with regulatory standards.
• Owns medium-to-complex inquiries into product-related incidents or failures, ensures thorough investigations, and effectively communicates risk findings and recommendations to senior management for informed decision-making and ensure that proactive risk mitigation strategies are developed to maintain patient, user, and consumer safety.
• Manages process improvement initiatives to drive best in class efficiency and effectiveness in risk management.
• Develops and executes risk control measures to effectively minimize potential negative outcomes and enhance overall product safety and reliability.
• Manages initiatives to improve both internal and external risk communication strategies with stakeholders and customers, and actively engages in industry conferences, forums, and working groups to remain updated on evolving best practices and emerging trends in product risk management.

• Coordinate with Engineering and Medical Affairs to maintain safety documentation and risk controls.

• Monitor post-market data (e.g., complaints, CAPAs, NCRs, customer feedback) for safety implications.

• Failure and Safety Analysis: Evaluate system failures to identify potential safety risks and swiftly perform safety analyses on defects discovered within the ISCV system.

• Use Analysis: Examine the standard usage patterns of the ISCV cardiology information system for possible safety risks with full understanding of the intended use of the system.

• Risk Assessment: Conduct a systematic assessment of safety risks, categorizing them by hazard, harm, probability of occurrence (P1), probability of harm (P2), and severity.

• Risk Control Contribution: Collaborate with cross-functional teams to define and implement effective risk control measures.

• Documentation Management: Maintain comprehensive safety documentation within the design history file of the device in close cooperation with project core teams, ensuring coherence with project goals and facilitating easy access for auditing purposes.

• Post-Market Surveillance Mechanisms
• Health and Safety Monitoring
• Quality Management Systems (QMS)
• Quality Specifications
• CAPA Methodologies
• Continuous Improvement
• Regulatory Compliance
• Quality Risk Management
• Reliability Engineering
• Product Risk Management
 

Minimum required Education:
Bachelor's/Master's Degree in Medical Sciences, Engineering, Life or Physical Science, Computer Science/Software development or equivalent.

Minimum required Experience:
Minimum 15+ years of experience with Bachelor's OR Minimum 5+ years of experience with Master's in areas such as Medical Device Product Development, Post Market Surveillance, Quality Engineering or equivalent.

• Familiarity with safety risk management principles in accordance with 10 + years of experience including: FDA, 21 CFR Parts 803, 806, 820, ISO 13485, ISO 14971, ISO 9001, European Medical Device Directive (93/42/EEC), EU MDR,.

• Ability to work within a Quality Management System (QMS), with proficiency in contributing to the evolution of processes that meet regulatory requirements while remaining efficient and aligned with business goals.

• Mandatory expertise in Complaint Handling, Vigilance Reporting, and Post-Market Surveillance (PMS) with awareness of global timelines.

• Familiarity with tools such as Trackwise, Service Management Tools, and Analytics/KPI Dashboards.

• Understanding of ISO 14971 Risk Management, CAPA processes, and product lifecycle safety.

#LI #EnterpriseInformatics
 

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
Indicate if this role is an office/field/onsite role.
 

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.