Compliance Engineer - Product Safety & Compliance

Job Title

Compliance Engineer - Product Safety & Compliance

Job Description

Compliance Engineer - Product Safety & Compliance

In this role, you have the opportunity to

This position is responsible for performing electrical testing and evaluation of a variety of Medical products to the provisions of U.S., Canadian and other International product safety standards (e.g. IEC/ANSI AAMI / CSA 60601-1 and its Collateral and Particular standards) and; writing reports; and communicating with regulatory agencies.

You are responsible for

•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 are a part of

This position resides in the Sleep & Respiratory Care Business Group, a business group of Philips HealthTech. We are highly dynamic, ambitious and agile within a fast changing industry.

Our vision is to work hand-in-hand with our clinical and consumer customers to transform the personalized healthcare market to meet the significant demands caused by the increase of chronic conditions and an aging society. Our mission is to improve the quality of life for consumers and patients through better awareness, diagnosis, treatment, monitoring, and management of their conditions.

To succeed in this role, you should have the following skills and experience

•Bachelor's degree with at least 3 years of experience in electrical engineering/ product compliance testing.
•Experience interacting with 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)
• Highly passionate and positive infectious attitude who strives for high performance, product quality, and with attention to details.
• Experience working in an FDA regulated environment according to OSHA and site EHS rules and knowledge in the requirements of IEC/ISO 60601/80601 standards series for medical devices is preferred.
• Excellent communication skills, both written and verbal.

In return, we offer you

Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what's next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.

Why should you join Philips?
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

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.

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Contact

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