Product Safety Engineer

Posted 17 Days Ago
Be an Early Applicant
New Kensington, PA, USA
In-Office
102K-163K Annually
Senior level
Healthtech • Telehealth
The Role
Lead product safety and compliance for medical devices, interpret and apply IEC 60601/ISO 80601 standards, plan and oversee safety testing and certifications, support audits and lab processes, and collaborate with cross-functional teams to ensure regulatory compliance for respiratory care products.
Summary Generated by Built In
Job TitleProduct Safety Engineer

Job Description

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.

You're the right fit if:

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

  • You’re an independent and collaborative professional who communicates effectively with a variety of stakeholders and is comfortable influencing decisions related to product safety and compliance. You demonstrate initiative, ownership, and accountability while thriving in a highly technical environment.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

  • Learn more about our business.

  • Discover our rich and exciting history.

  • Learn more about our purpose.

  • Learn more about our culture.

Philips Transparency Details

The pay range for this position in New Kensington, PA is $102,000 to $163,000.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.   

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered.  Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.  Details about our benefits can be found here. 

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. 

Additional Information

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.

Company relocation benefits will not be provided for this position.  For this position, you must reside in or within commuting distance to New Kensington, PA.

 #ConnectedCare

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.  Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

Skills Required

  • 5+ years supporting product safety, compliance, and certification activities for medical devices
  • Experience planning, executing, and overseeing product safety testing and working with external testing and certification organizations
  • Knowledge and experience interpreting and applying IEC 60601 and ISO 80601 medical device safety standards
  • Bachelor's degree in Electrical, Mechanical, Biomedical, or another Engineering discipline
  • Master's degree
  • Experience with electromagnetic compatibility (EMC) testing, wireless compliance, respiratory medical devices, or AI tools/technologies
  • Onsite lab-support role requiring residency or commuting distance to New Kensington, PA and in-person collaboration (office-based at least 3 days/week)
  • US work authorization without sponsorship (candidates requiring visa sponsorship will not be considered)

Philips Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Philips and has not been reviewed or approved by Philips.

  • Retirement Support Retirement support is positioned as a standout, including a strong 401(k) match (often described at 7%) alongside pensions in some contexts.
  • Flexible Benefits Flexible benefits are emphasized through choice in health insurance options and a broad “Total Rewards” approach that combines compensation, health and wellness, and work-life support.
  • Leave & Time Off Breadth Leave and time off breadth appears strong, with generous paid time off and policies covering parental leave, caregiving responsibilities, volunteering, and family medical leave.

Philips Insights

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The Company
HQ: Cambridge, MA
80,000 Employees
Year Founded: 1891

What We Do

Do the work of your life to help the lives of others. As a leading health technology company, it is our purpose to improve people’s health and well-being through meaningful innovation. Our goal is to improve 2.5 billion lives per year by 2030. ​ ​ We also strive to be the best place to work for people who share our passion, by promoting personal development, inclusion and diversity while acting responsibly towards our planet and society.

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