Product Safety Engineer

Philips

New Kensington (Westmoreland County)

On-site

USD 102,000 - 163,000

Full time

14 days+

Get more replies from employers

Send a job-specific resume in minutes.

Benefits offered by this job

PTO
401(k) match
Health Savings Account
Stock purchase plan
Education reimbursement

Job summary

Philips in New Kensington, PA is seeking a Product Safety Engineer to lead safety and regulatory activities across the product lifecycle for Sleep & Respiratory Care devices. You will interpret IEC 60601 standards, perform risk assessments, coordinate with engineering and testing partners, and support audits and certification efforts in an onsite lab role based near Pittsburgh.

This role requires 5+ years of relevant experience and a Bachelor's degree in engineering; Master’s is preferred.

Qualifications

  • 5+ years of experience in product safety, compliance, and certification for medical devices.
  • Experience interpreting IEC 60601 and ISO 80601 requirements.

Responsibilities

  • Lead product safety and compliance activities for medical devices throughout the lifecycle.
  • Interpret and apply IEC 60601 standards to designs and provide guidance to engineering teams.
  • Plan, execute, and oversee safety testing and certification with external labs.
  • Support audits, inspections, and accreditation activities and maintain lab procedures.
  • Collaborate with engineering, quality, regulatory, manufacturing, and external partners onsite.

Skills

IEC 60601 knowledge
Medical device safety
Regulatory compliance
Risk assessment

Education

Bachelor's degree in Engineering
Master's degree preferred

Tools

Electrical testing equipment

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.
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, 401(k) (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.

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

Get your free, confidential resume review.
or drag and drop your file here.
Similar jobs

Similar jobs worth comparing

Product Safety Engineer – Medical Devices
Product Safety Engineer – Medical Devices

Philips • New Kensington

On-site
USD 102,000 - 163,000
PTO
401(k) match
Health Savings Account
+2
Systems Engineer
Systems Engineer

Philips International • New Kensington

On-site
USD 102,000 - 163,000
Generous PTO
401k with up to 7% match
Education reimbursement
Head of Regulatory, AM & D
Head of Regulatory, AM & D

Philips • Cambridge (MA)

On-site
USD 183,000 - 291,000
PTO (Paid Time Off)
401k match
HSA with company contribution
+2
Senior Design Quality Engineer
Senior Design Quality Engineer

Philips • San Diego (CA)

On-site
USD 103,000 - 145,000
PTO
401k match
HSA with company contribution
+2
Head of Quality, Ambulatory Monitoring & Diagnostics
Head of Quality, Ambulatory Monitoring & Diagnostics

Mass Digital Health • Massachusetts

On-site
USD 219,000 - 349,000
PTO
401k match
HSA
+2
Head of Quality, Ambulatory Monitoring & Diagnostics
Head of Quality, Ambulatory Monitoring & Diagnostics

Philips • Cambridge (MA)

On-site
USD 219,000 - 349,000
Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist

Mass Digital Health • Massachusetts

On-site
USD 105,000 - 168,000
Generous PTO
401k (up to 7% match)
HSA (with company contribution)
+1
Software Design Quality Engineer
Software Design Quality Engineer

Philips International • Bedford (MA)

On-site
GBP 76,000 - 121,000
PTO
401k
HSA
+5
Head of Regulatory, AM & D
Head of Regulatory, AM & D

Mass Digital Health • Massachusetts

On-site
USD 183,000 - 291,000
PTO
401k up to 7% match
Stock purchase plan
Site Leader (Director), Operations Quality Assurance-Ultrasound
Site Leader (Director), Operations Quality Assurance-Ultrasound

Philips • Reedsville (WI)

On-site
USD 162,000 - 258,000