Product Safety Engineer

About the role

Lead product safety and compliance efforts that help bring innovative Sleep & Respiratory Care technologies to patients around the world. Your Role: Lead product safety and compliance activities for medical devices, helping ensure products meet regulatory requirements and internal quality standards throughout the product lifecycle.

Responsibilities

• Support safety testing, risk assessments, and compliance decision-making for complex medical technologies
• Serve as a product safety subject matter expert by interpreting and applying International Electrotechnical Commission (IEC) 60601 standards to product designs
• Partner closely with engineering teams to provide guidance, evaluate compliance requirements, and recommend design solutions
• Plan, execute, and oversee product safety testing and certification activities for a portfolio of respiratory care products
• Work with external testing and certification organizations to support timely approvals and ongoing compliance
• Support audits, inspections, and accreditation activities while helping maintain and improve laboratory processes, procedures, and documentation
• 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 and drive continuous improvement

Requirements

• 5+ years of experience supporting product safety, compliance, and certification activities for medical devices in a regulated environment
• Experience with product safety testing and working with certification organizations is highly valued
• Skills include interpreting and applying medical device safety standards, including International Electrotechnical Commission (IEC) 60601 and International Organization for Standardization (ISO) 80601 requirements
• Bonus skills include experience with electromagnetic compatibility testing, wireless compliance requirements, respiratory medical devices, or Artificial Intelligence tools and technologies
• A Bachelor’s degree in Electrical, Mechanical, Biomedical, or another Engineering discipline; a Master’s degree is preferred

Qualifications

• Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position

Skills

• Independent and collaborative professional who communicates effectively with a variety of stakeholders
• Communicates effectively with a variety of stakeholders
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