Product Safety & Compliance Engineer - Medical Devices

Philips Iberica SAU; 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

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.