Product Safety Engineer

Product Safety Engineer (New Kensington, PA)

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. You will 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. You will 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. This includes working 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. You will also 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. This is an onsite lab‑support role based in Pittsburgh, where regular in‑person collaboration is expected.

• Lead product safety and compliance activities for medical devices, helping ensure products meet regulatory requirements and internal quality standards throughout the product lifecycle.
• 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 maintaining and improving 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.
• Work in an onsite lab‑support role based in Pittsburgh, where regular in‑person collaboration is expected.

• You’ve acquired 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.
• Your 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.
• You have a Bachelor’s degree in Electrical, Mechanical, Biomedical, or another Engineering discipline; a Master’s degree is preferred.
• You…