Philips Sr Engineer V&V in Monroeville, Pennsylvania

Job duties include, but are not limited to:

  • Work with a team to assess products for compliance to international biological standards.

  • Document biological test strategies and manage testing with outside test labs.

  • Learn from and adhere to internal quality manual (Quality System Procedures, Work Instructions, Forms).

  • Maintain and update current biocompatibility Quality System Procedures, Work Instructions, and Forms.

  • Develop and conduct biocompatibility training programs.

  • Develop V&V test plans, test procedures, and test reports.

  • Review requirements and scrutinize for testability.

  • Quickly learn to use automated test tools and specialty test equipment; develop and validate automated test scripts.

  • Execute test procedures both personally and using test technicians.

  • Log defects and issues found during V&V activities and track to closure.

  • Perform regression analysis and determine testing associated with design changes.

  • Provide weekly project status reports.

  • Prioritize project tasks to complete on schedule while maintaining quality of work.

  • Work in a team environment; peer review work.

  • Work on multiple, concurrent projects.

In this role, you have the opportunity to

Work under direct supervision of the V&V Lead to produce clear and concise V&V documents for medical devices. Focus will be assessing and testing materials for compliance to ISO 10993 and ISO 18562. Additional responsibilities of testing hardware at the system level, with some knowledge of sub-system and software level testing preferred.

You are responsible for

  • Work with a team to assess products for compliance to international biological standards.

  • Document biological test strategies and manage testing with outside test labs.

  • Learn from and adhere to internal quality manual (Quality System Procedures, Work Instructions, Forms).

  • Maintain and update current biocompatibility Quality System Procedures, Work Instructions, and Forms.

  • Develop and conduct biocompatibility training programs.

  • Develop V&V test plans, test procedures, and test reports.

  • Review requirements and scrutinize for testability.

  • Quickly learn to use automated test tools and specialty test equipment; develop and validate automated test scripts.

  • Execute test procedures both personally and using test technicians.

  • Log defects and issues found during V&V activities and track to closure.

  • Perform regression analysis and determine testing associated with design changes.

  • Provide weekly project status reports.

  • Prioritize project tasks to complete on schedule while maintaining quality of work.

  • Work in a team environment; peer review work.

  • Work on multiple, concurrent projects.

You are a part of

Our group works closely with the development team throughout the product development process. We play an active roll early on in ensuring requirements are complete, unambiguous, and testable, collaborate to develop detailed test plans, and assist with development testing prior to the verification and validation phase. While having our own responsibilities within the group, we look to each other’s strengths for support in doing our jobs.

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

  • Bachelor’s Degree in Material Science with emphasis on Plastics and Polymers.

  • 3-5 years professional experience.

  • Knowledge of biological test methods.

  • Familiarity with FDA 2016 Guidance Document “Use of International Standard ISO 10993-1.”

  • Experience conducting biological assessments of medical devices.

  • Experience documenting biological test evidence to support FDA submittals.

  • Experience working with outside test labs to generate test plans and evaluate results for compliance to biological standards.

  • Basic understanding of global medical device regulations, requirements, and standards preferred.

In return, we offer you

At Philips, you will have the opportunity to work with a team that puts people first, and strives to improve people’s lives through meaningful innovation.

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.

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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