Philips Product Safety Engineer 

United States, Massachusetts 

920299986

Philips Hospital Patient Monitoring Hardware Test Engineering team is seeking a Product Safety Engineer who will support compliance verification for various medical equipment and information technology equipment programs.

Your role:

• Provide applicable standards advice to development teams in regards to product specifications, compliance verification, risk management, usability engineering, software process requirements, basic safety constructional requirements, marking and information for safety.
• Prepare safety evaluation planning documents in order to support the estimation of project time requirements and support project schedules as well as preparing a clear plan of all executable actions required to fulfill compliance requirements.
• Work with regulatory, quality, program/project managers, electrical/mechanical/software engineers in order to ensure standards requirements are addressed.
• Support the ASRC’s ISO 17025 quality management system. Including involvement in audits including witness testing, owning corrective or improvement actions, conducting software validations for test system development, writing work instructions and providing group training for assigned topics.
• Lead and or support department development projects that are meant to improve productivity (e.g. identify and purchase new equipment, better tools, maintain equipment preventive maintenance, repairs and calibrations).
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this.

You're the right fit if:

• BS Electrical Engineering, BS Electrical Technology or BS Biomedical Engineering, ASEE (or ASET).
• 5+ years of experience in product safety compliance testing.
• Knowledge in product safety standards requirements, preferably for medical devices.
  • IEC/ISO 60601/80601 medical equipment standards
  • IEC 62368-1 audio, video, information and communication technology equipment standards
• Solid fundamentals in electrical engineering circuit concepts and electrical test equipment purpose, operation and functionality.
• Preferred experience working in an FDA regulated environment in accordance with OSHA and site EHS rules.
• 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 benefitswill notbe provided for this position. For this position, you must reside inorwithin commuting distance to Andover, MA.

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.

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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion.

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.

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.