#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.

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.

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.

• Read more about our employee benefits.

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 here.

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

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It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

Equal Employment and Opportunity Employer/Disabled/Veteran