Product Safety Engineer – Medical Devices

About the role

Lead product safety and compliance activities for medical devices, ensuring regulatory and internal quality standards are met throughout the product lifecycle. This onsite lab‑support role is based in New Kensington, PA.

Key responsibilities

• Plan, execute, and oversee product safety testing and certification for respiratory care products, coordinating with external testing and certification bodies.
• Interpret and apply IEC 60601 and ISO 80601 standards to product designs, providing guidance to engineering teams.
• Support audits, inspections, and accreditation activities while maintaining laboratory processes and documentation.
• Monitor evolving regulations and assess their impact on current and future products.
• Collaborate with engineering, quality, regulatory, manufacturing, and external partners to solve complex safety challenges.

Required profile

• 5+ years of experience in product safety, compliance, and certification for medical devices in a regulated environment.
• Bachelor’s degree in Electrical, Mechanical, Biomedical, or related engineering discipline; Master’s preferred.
• US work authorization and residence within commuting distance to New Kensington, PA.

Required skills

• Expertise with IEC 60601 and ISO 80601 safety standards.
• Experience in electromagnetic compatibility (EMC) testing and wireless compliance.
• Knowledge of respiratory medical device testing and AI tool integration.
• Product safety testing and certification processes.

What we offer

• Salary range $102,000 – $163,000 per year.
• Annual incentive bonus and long‑term incentive opportunities.
• Comprehensive benefits including generous PTO, 401(k) match up to 7%, HSA contributions, stock purchase plan, and education reimbursement.