Philips Sustaining Senior Design Assurance Engineer 

United States, California, San Diego 

341182986

Sustaining Senior Design Assurance Engineer

Your role:

• Provide quality engineering support and leadership for products which includes launch and stabilization through concept, design, and development as well as representing and providing quality engineering support on commercially launched products through sustaining initiatives (design, supplier, obsolescence changes).
• Lead and support the development/update of product requirements, design verification strategies, design validation strategies and update of design trace matrices/DHF files in support of product design changes.
• Participate in design reviews to ensure all pre-defined requirements have been met.
• Lead the risk management process and on-going maintenance of the risk management file (Risk Management Plan, FMEAs, Hazard Analysis, Risk Management Report). Ability to perform risk assessments for product changes (design, supplier, obsolescence) and update of the risk documentation as necessary.
• Lead the investigation of complex product issues (CAPAs, NCRs, Issue Impact Assessments) and recommend appropriatepreventive/correctiveactions.
• Monitoring/trending of product issues/complaints and initiating appropriate quality planning principles to resolve such issues.
• Ability to use quality tools for effective problem solving (5 Why, Pareto, Fish bone, FMEA).
• Maintain knowledge of current regulatory requirements, applicable laws and standards as well as internal quality system requirements.
• Represent Philips as appropriate in FDA, notified body, internal and external audits.
• Mentoring of junior staff that includes training, motivating and monitoring.
• Other duties as assigned or required.

You're the right fit if:

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

• Bachelor's Degree in Engineering (Electrical Engineering, Bio-Medical Engineering) with a minimum of 5 years experienceora Master's Degree in Engineering (Electrical Engineering, Bio-Medical Engineering) with a minimum of 3 years experience.
• Experience working in a regulated industry with full working knowledge of 21 CFR 820, ISO 13485 and ISO14971 medical device/safety requirements.
• Strong knowledge/experience with CAPAs, NCRs and product issue impact assessments through the corrections and removals evaluation process.
• Knowledge of electrical engineering principles with respect to systems, sub-systems and components. Ability to thoroughly understand complex hardware systems and understanding of how the system works/operates.
• Self-motivated individual and a self-starter that can work independently with minimal supervision.
• Strong interpersonal skills, organizational skills and project management skills.
• Strong oral, presentation and technical writing skills.
• Demonstrated skills in decision making/problem solving and the ability to lead project teams whenroadblocks/challengesexist.
• Use of statistical analysis techniques and software for basic data interpretation (Minitab preferred).
• Use of various tools including microscopes, multimeters and other inspection equipment.
• Proficient in relevant software programs (Microsoft Word, PowerPoint, Excel and Project).

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .

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US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.