Philips Product Safety/Compliance Engineer in Andover, Massachusetts
In this role, you have the opportunity as a Product Safety Engineer to play a very important role in ensuring products designed by Philips are of the highest quality and comply with national and international standards requirements.
You are responsible for
Provide standards compliance consultation to our various business lines during product development including standards based risk management requirements, usability requirements, software requirements, essential performance requirements and clinical accuracy requirements;
Plan, schedule, manage, conduct and support business clients and ASRC staff with projects assigned;
Support project tests by advising, planning, verifying test methods and reviewing and signing test results and at times conducting tests;
Conduct product reviews (IFU, Marking, Risk Management, Essential Performance, Software Life-Cycle Development and Usability) and inspections (Creepage Distance, Air Clearance, Alarms) according to standards requirements;
Facilitate and maintain constant communications with associate project engineers, technicians and group manager;
Prepare formal product safety compliance verification reports for submittal to Third-party agencies and DHF verification vault;
Work with Third-party agencies to obtain product certifications;
Participate in audits conducted by Third-party agencies and our ISO 17025 accrediting firm;
Participate in the product safety groups’ ISO 17025 quality management system including annual proficiency testing, training, corrective actions, preventive actions, audit action plan reports, action items from management reviews and participating in authoring or editing documentation and improving documentation efficiency;
Own standards within the groups scope of accreditation as assigned by the group manager, where your responsibilities will include influencing standards and TRF requirements, test equipment needs and training ASRC staff relative to requirements;
Participate in product safety group training events and meetings meant to enhance the teams knowledge, work process and output consistency and efficiency efforts;
You are a part of
- This is a key and critical role within the Andover Standards and Reliability Center (ASRC) Group at Philips Healthcare in Andover, MA. This is an opportunity to be part of an experienced, winning team that performs product safety compliance verification for all medical product lines within Philips Andover. The product safety team plays a very important role in ensuring products designed by Philips are of the highest quality and comply with national and international standards requirements
To succeed in this role, you should have the following skills and experience
BSEE (or BSET) with 5+ years’ experience in product compliance verification engineering, preferably for medical devices;
Experienced with product safety standards requirements for medical devices (IEC/ISO 60601/80601);
Experienced in standards based risk management requirements, usability requirements, software requirements, essential performance requirements and clinical accuracy requirements;
Demonstrated success in project management fundamentals and managing projects;
Demonstrated success in preparing formal product safety compliance verification test reports for submittal to Third-party agencies and obtaining product certifications;
Solid experience working in an FDA regulated environment according to OSHA and site EHS rules;
Highly passionate and positive infectious attitude who strives for high performance, product quality, and with attention to details;
The ability to work well in a team and possessing the skills and the ability to work independently to get things done efficiently and timely;
Demonstrated competence in methodical and effective troubleshooting. Excellent problem solving skills (root cause analysis);
Organized with strong detail focus and the ability to write thorough, accurate documentation of test results, test procedures, test forms and quality management system records;
Solid fundamentals in electrical engineering circuit concepts and electrical test equipment.
Proficient in standard office computer tools: Microsoft Office, Word, Excel, Project, PowerPoint and Visio;
Excellent communication skills, written and verbal
In return, we offer you
Sharpen your talents with new challenges in our dynamic organization. As a market-driven company, we’re used to listening to our customers & apply the same thinking to our employees. We offer a competitive salary, outstanding benefits and flexibility in a career with a positive and supportive atmosphere in which to develop your talents further.
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.