Sr. Quality/Electrical Engineer - Product Safety & Compliance

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 a well-seasoned 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.
Your responsibilities
+ 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;
+ Review test results and when necessary conduct testing
+ Conduct product reviews and inspections according to standards requirements
+ Facilitate and maintain constant communications with associate project engineers, technicians and manager
+ Prepare formal product safety compliance verification test reports for submittal to Third-party agencies
+ Work with Third-party agencies to obtain product certifications
+ Support audits conducted by Third-party agencies and our ISO 17025 accrediting firm
+ Support 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 assigned by Technical Lead Engineer 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 and meetings meant to enhance the teams knowledge, work consistency and efficiency efforts
Your Profile
+ BSEE (or BSET) with 10+ 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
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. fa09d29d756b4e04b27beb84ef762118

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