Product Safety Engineer

About the Role Lead product safety and compliance for Philips Sleep & Respiratory Care medical devices, ensuring regulatory alignment and internal quality standards throughout the lifecycle. You will guide safety testing, risk assessments, and compliance decisions, interpreting IEC 60601 standards to inform design and validation. This role partners with engineering, quality, regulatory, and manufacturing teams to solve complex safety challenges and enable timely approvals. What You'll Do

• Lead product safety and compliance activities for medical devices across the product lifecycle.
• Plan, execute, and oversee product safety testing and certification activities, including collaboration with external testing and certification organizations.
• Perform risk assessments and support safety decision-making to maintain regulatory and internal quality standards.
• Interpret and apply IEC 60601 standards to product designs and provide guidance to engineering teams.
• Monitor evolving regulations and standards and assess their impact on current and future products.
• Collaborate with engineering, quality, regulatory, manufacturing, and external partners to solve complex product safety challenges.
• Support audits, inspections, and accreditation activities; help maintain and improve laboratory processes, procedures, and documentation.
• Partner closely with engineering teams to evaluate compliance requirements and recommend design solutions. What We're Looking For
• Deep knowledge of IEC 60601 standards and their application to medical device designs.
• Experience leading product safety and compliance activities across the lifecycle of medical devices.
• Proven ability to plan and oversee safety testing, risk assessments, and certifications; experience working with external labs and certification bodies.
• Strong risk management skills and ability to make safety-driven regulatory decisions.
• Excellent collaboration and communication across engineering, quality, regulatory, manufacturing, and external partners.
• Experience in Sleep & Respiratory Care or related medical device domains is a plus.
• Ability to interpret regulatory standards and guide product design accordingly.