Philips Safety Compliance Lab Manager in New Kensington, Pennsylvania15068

Safety Compliance Lab Manager

You are responsible for

This position is responsible for managing a lab that performs safety compliance 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).

Responsibilities

  • Manage day-to-day lab activities including supervision and development of 10 engineers and technicians

  • Manage $3Million Capital Equipment and Lab budget

  • Review emerging regulations and changing standards for potential impact to business. Propose compliance plans to meet changing requirements.

  • Interface and participate 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 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.

Skills and experience

  • BS. Electrical Engineering (preferred) or Mechanical Engineering.

  • Demonstrated, hands on, 10 + years’ experience in lab management (including knowledge about compliance testing, obtaining certification to safety standards for medical devices, equipment calibration etc).

  • 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)

  • Familiarity with global product safety and EMC standards (e.g. IEC 60601-1 and IEC 60601-1-2 and Collateral and Particular standards for ventilators, sleep apnea devices, oxygen concentrators etc)

  • Experience with wireless compliance standards is a plus.

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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .

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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Safety Compliance Lab Manager

You are responsible for

This position is responsible for managing a lab that performs safety compliance 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).

Responsibilities

  • Manage day-to-day lab activities including supervision and development of 10 engineers and technicians

  • Manage $3Million Capital Equipment and Lab budget

  • Review emerging regulations and changing standards for potential impact to business. Propose compliance plans to meet changing requirements.

  • Interface and participate 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 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.

Skills and experience

  • BS. Electrical Engineering (preferred) or Mechanical Engineering.

  • Demonstrated, hands on, 10 + years’ experience in lab management (including knowledge about compliance testing, obtaining certification to safety standards for medical devices, equipment calibration etc).

  • 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)

  • Familiarity with global product safety and EMC standards (e.g. IEC 60601-1 and IEC 60601-1-2 and Collateral and Particular standards for ventilators, sleep apnea devices, oxygen concentrators etc)

  • Experience with wireless compliance standards is a plus.

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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .

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.

XLI-MR1