Philips Sustaining Senior Design Assurance Engineer 

United States, California, San Diego 

356462547

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 appropriate preventive/corrective actions.

• Monitoring/trending 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 including training, motivating and monitoring.

You're the right fit if:

• You’ve acquired 3+ years of experience with electrical engineering principles with respect to systems, sub-systems and components. Ability to thoroughly understand complex hardware systems and how the systems work/operate.

• Your skills include 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.

• You have a bachelor's degree in engineering (electrical engineering, bio-medical engineering) with a minimum of 5 years of experience or a master's degree in engineering (electrical engineering, bio-medical engineering) with a minimum of 3 years of experience.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

• You’re a self-motivated individual and a self-starter who can work independently with minimal supervision. Strong interpersonal skills, organizational skills and project management skills are essential.

This is an office role.

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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The pay range for this position in California is $97,440 to $155,904 annually.