Compliance Engineer, Product Safety & Compliance

Philips; New Kensington (Westmoreland County); On-site; USD 74,000 - 117,000; Full time

Benefits offered by this job

Generous PTO

401k with company match

HSA with company contribution

Stock purchase plan

Education reimbursement

Job summary

Philips Iberica SAU is seeking a Compliance Engineer for Product Safety & Compliance in New Kensington, PA. You will support safety testing, validation, and regulatory submission to ensure healthcare devices meet global standards.

The role requires collaborating with certification bodies, conducting tests, and maintaining documentation to demonstrate ongoing compliance within a regulated environment.

Qualifications

• 1+ years of experience supporting product safety, compliance, and certification activities for medical devices.
• Experience with product safety testing and working with certification organizations is highly valued.
• Bachelor's degree in Electrical, Mechanical, Biomedical or another Engineering discipline.

Responsibilities

• Perform tests to comply with current global product safety standards (IEC 60601-1 and its Collateral/Particular standards).
• Develop and set up test plans and run standard test equipment.
• Submit test reports to regulatory agencies for final approval.
• Review emerging regulations and propose compliance plans.
• Interface with certification agencies during site inspections.
• Coordinate with external testing & certification suppliers to ensure cost-effective strategies.
• Assist product development and manufacturing in maintaining compliance data.

Skills

Product safety

Certification processes

Electrical safety standards

IEC 60601 knowledge

ISO 80601 knowledge

Electromagnetic compatibility

Wireless compliance

MS Office

Education

Bachelor's degree in Engineering

Tools

Power meter

Power analyzer

Data logger

Oscilloscope

Spectrum analyzer

Job description

Job Title

Compliance Engineer, Product Safety & Compliance (New Kensington, PA)

Job Description

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

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