Product Safety Engineer

Philips•Alvin, TX

1d•Onsite

About The Position

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.

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.
Skills include interpreting and applying medical device safety standards, including International Electrotechnical Commission (IEC) 60601 and International Organization for Standardization (ISO) 80601 requirements.
Bachelor’s degree in Electrical, Mechanical, Biomedical, or another Engineering discipline.
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
Independent and collaborative professional who communicates effectively with a variety of stakeholders and is comfortable influencing decisions related to product safety and compliance.
Demonstrates initiative, ownership, and accountability while thriving in a highly technical environment.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
Must reside in or within commuting distance to New Kensington, PA.

Nice To Haves

Experience with electromagnetic compatibility testing.
Experience with wireless compliance requirements.
Experience with respiratory medical devices.
Experience with Artificial Intelligence tools and technologies.
Master’s degree is preferred.

Responsibilities

Lead product safety and compliance activities for medical devices, ensuring 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 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.