Philips Principal Design Assurance Electrical Engineer Hybrid 

United States, California, San Diego 

234331162

Principal Design Assurance Engineer (San Diego-Hybrid, 3 days onsite weekly)

The Principal Design Assurance Engineer will be responsible for providing quality engineering support and leadership for New Product Development that 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).

Your role:

• Drives the development of product requirements, verification strategies, and validation strategies to ensure the detection of defects at earliest phase of product design lifecycle.
• Review and approve design control, manufacturing, quality, engineering, and verification/validation documents in their relevant design phases for successful design phase closure. Monitoring/trending of product issues/complaints and initiating appropriate quality planning principles to resolve such issues.
• Develop inspection and sampling plans, test methods, and transfer criteria for new products. Provide support and expertise in developing and executing a reliability strategy during new product development.
• Lead the risk management process per ISO 14971 and the creation/maintenance of the Risk Management File. Ability to perform risk assessments for product changes (design, supplier, obsolescence) and update of the risk documentation, as necessary. Lead and provide guidance to cross functional teams to ensure design control requirements are being followed during design verification and validation activities. Lead the investigation of complex product issues (CAPAs, NCRs, Issue Impact Assessments) and recommend appropriate preventive/corrective actions.
• 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, motivation, and monitoring.

You are the right fit if:

• You have acquired 8+ years of experience working in a regulated industry with full working knowledge of 31 CFR 820, ISO 13485, ISO 14971, and IEC 60601 medical device/safety requirements. Experience driving risk management discussions, specifically as it relates to cascading identified product issues/hazards into potential user harms. Certified Quality Engineer (CQE) certification strongly preferred. Experience with medical device hardware/software systems with experience leveraging software as a medical device (SaMD), design of experiments, reading and interpretation of schematics/drawings, and strong knowledge of electrical safety standards (ISO/IEC) and working experience utilizing standards are all preferred.
• Your skills include a strong knowledge of electrical engineering principles with respect to systems, sub-systems, and components. You thoroughly understand complex hardware systems and understand how the system functions. 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). Proficient in math and use of advanced statistical techniques. Six Sigma Certification preferred.
• You have a bachelor’s degree in engineering (Electrical Engineering or Biomedical Engineering) with a minimum of 8 years’ experience or a master’s degree in engineering with a minimum of 6 years’ experience. Electrical Engineering strongly preferred.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• You are a self-motivated individual and a self-starter that can work independently with minimal supervision. You have strong interpersonal and communication skills (oral, presentation, and writing). You have demonstrated skills in decision making/problem solving and the ability to lead project teams when roadblocks/challenges exist.

We are a health technology company. We built our entire company around the belief that every human matters, and we will not 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 are interested in this role and have many, but not all, of the experience 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.

be provided for this position. For this position, you must reside inwithin commuting distance to San Diego