Compliance Engineer, Product Safety & Compliance (New Kensington, PA)
You will be a part of product safety and compliance efforts that help bring innovative Sleep & Respiratory Care technologies to patients around the world.
Your role:
- Perform tests to comply with current global product safety standards (e.g. IEC 60601-1 and its Collateral and Particular standards
- Complete preliminary design reviews. Develop and set up test plans. Set up and operate standard test equipment including, but not limited to, Power Meter or power Analyzer, Data logger, spectrum analyzer, oscilloscope, dielectric strength tester, ground continuity tester, digital multi-meter, surge generator, over-voltage tester, environmental condition chamber etc. Core tests include, but are not limited to: Power Input or rating, leakage current, dielectric, temperature, pressure, stability, mechanical hazard, flammability, abnormal operations or single faults, rain, radiation, sound etc.
- Compile test results during construction review and testing. Submit report to regulatory agency for final approval.
- Review emerging regulations and changing standards for potential impacts. Propose compliance plans to meet changing requirements.
- Interface and participate, as needed, in site inspections from certification agencies.
- Act as liaison with external testing & certification suppliers to assure accurate and cost-effective test strategies are implemented in a timely manner and documented in accordance with applicable global standards.
- Assist product development and manufacturing maintain proper testing & product configuration data to demonstrate continued compliance.
You're the right fit if:
- You’ve acquired 1+ 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 the ability to work independently & proven proficiency in project management, problem solving, and MS Office tools (Word, PowerPoint, etc)
- You have a Bachelor’s degree in Electrical, Mechanical, Biomedical, or another Engineering discipline.
- 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 $74,000 to $117,000.
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
- At least 1 year of experience supporting product safety, compliance, and certification activities for medical devices in a regulated environment
- Experience interpreting and applying medical device safety standards, including IEC 60601 and ISO 80601
- Bachelor's degree in Electrical, Mechanical, Biomedical, or another Engineering discipline
- Proficiency with MS Office tools, including Word and PowerPoint
- Ability to work independently and demonstrate project management and problem-solving skills
- Effective communication and collaboration with technical stakeholders, certification organizations, suppliers, product development, and manufacturing teams
- Ability to work in person at least 3 days per week in an office role
- US work authorization without current or future visa sponsorship
- Residence in or within commuting distance of New Kensington, Pennsylvania
- Experience with product safety testing and certification organizations
- Experience with electromagnetic compatibility testing, wireless compliance, respiratory medical devices, or artificial intelligence tools and technologies
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.
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Retirement Support — Retirement support is positioned as a standout, including a strong 401(k) match (often described at 7%) alongside pensions in some contexts.
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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.
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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
What We Do
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're always looking for ways to make life better – not only for our customers, but also for everyone working here. That's why we're taking steps to create an environment where we all acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.
