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Product Safety Engineer
4 months ago
Job Title
Product Safety Engineer
Job Description
#509607 Product Safety Engineer CG-60 (New Kensington)
We have an exciting opportunity for a Product Safety Engineer for Philips S&RC (Sleep and Respiratory Care Division. You will join a team responsible for the structured analysis of product safety/compliance incidents in the market including initiating follow-up and completing the appropriate remediation.
Your role:
Ensures BG/local commitment to product safety/compliance and signs off declarations on product safety/compliance and compliance on behalf of BG/site management.
Leads all product safety/compliance related activities in the SVAL/BG/Site to ensure that the regulations and policies are fully and timely available and interpreted, products comply with all regulatory requirements and Philips policies and incidents are handled according to corresponding product safety/compliance incident handling process including review and decision making on product safety/compliance related escalations.
Makes and/or validates independent product safety risk assessments in line with conflict-of-interest rules and Philips & regulatory standards.
Responsible for leading Safety/Compliance engineering activities like:
Designing/safety/compliance plans,
overseeing the execution of safety/compliance plans,
executing safety/compliance plans
assessing safety/compliance of complex designs,
reviewing test and other complex performance data, analyses market
feedback, lead complex root cause analysis and complex
safety/compliance problem solving
May also provide other safety/compliance engineering support, including assisting organizational units in leading resolution of safety/compliance engineering deficiencies,
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.
Review emerging regulations and changing design standards for potential impacts. Propose compliance plans to meet changing requirements.
Interface and participate, as needed, in site inspections from certification agencies.
You're the right fit:
You’ve acquired 5 + years’ experience of product designs to applicable IEC 60601 standards.
Bachelor of Science in Engineering (higher preferred) and 5 years’ experience in testing and obtaining certification to safety standards for medical devices preferred.
Experience interacting with Notified Bodies, certification and regulatory agencies and participating in audits.
Possess excellent verbal and written communication skills as well as interpersonal skills necessary to work across multiple engineering disciplines, and project management.
Ability to work independently & proven proficiency in project management, problem solving, and MS Office tools (Word, PowerPoint, etc)
Experience with wireless compliance and knowledge of EMC testing & standards 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.
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 be provided for this position. For this position, you must reside in within commuting distance to New Kensington, PA.
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.
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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 .
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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.
