Sustaining Senior Design Assurance Engineer

Job Title
Sustaining Senior Design Assurance Engineer

Job Description

Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all.

In this role you have the opportunity to

At Philips, we're looking for a highly qualified Senior Design Assurance Engineer (sustaining) to join our team within the San Diego site (note that this role requires the individual to be onsite minimum of 3 days a week). We're looking for someone with the experience, drive, and passion to help us continue to provide the highest quality products to our customers. Our ideal candidate will have extensive experience in design quality engineering, as well as a proven track record of success in the field. The Senior Design Assurance Engineer will be responsible for qualifying, supporting and maintaining the design lifecycle of image guided therapy consoles and patient interface modules from concept to commercialization and through its end of life. The successful candidate will be a confident problem solver, able to identify potential issues and implement solutions, while ensuring that all products meet the highest quality standards. This individual will be expected to apply their knowledge of design control principles, statistics, process/systems validation and quality engineering techniques to positively influence sustaining engineering and remediation projects. This individual shall also ensure changes to products are developed and manufactured to applicable industry standards, regulatory requirements and customer requirements.

• 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 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.

• Bachelor's Degree in Engineering (Electrical Engineering, Bio-Medical Engineering) with a minimum of 5 years experience or a 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 when roadblocks/challenges exist.
• 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).

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