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 toAt 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.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 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 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).
About PhilipsWe 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 here.Philips Transparency DetailsThe pay range for this position is $77,000,000 to $136,000, Annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.Additional InformationUS 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.#LI-PHI#LI-HYBRIDIt is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.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.Equal Employment and Opportunity Employer/Disabled/Veteran