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Senior Design Quality Assurance Engineer

In this role you

The Senior Design Quality Engineer is accountable for oversight of system and hardware quality and risk management throughout the product life cycle. The Senior Design Quality Engineer provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. The Senior Design Quality Engineer also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes.

Your role:

+ Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design

+ Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs

+ Provides effective oversight of the execution of the Quality Plan , any Risk Management activities, and of all design related activities during the product/system lifecycle

+ Performs independent technical assessment on product quality performance and post-market product quality analysis

+ Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required

You're the right fit if:

+ Bachelor's/Master's Degree Engineering or equivalent

+ 5+ years of experience in Product development, Design Quality, Risk Management for medical device.

+ Knowledge of 13485 / 9001 / FDA / Canada / 14971/ standards

+ FMEA/ Root Cause Analysis/ Problem solving

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

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office role.

About Philips

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.

+ Learn more about our business.

+ Discover our rich and exciting history.

+ Learn more about our purpose.

+ Learn more about our culture.

Philips Transparency Details

The pay range for this position in Plymouth MN is $92,000 to $135,000 Annually.

The actual base pay offered may vary within the posted ranges 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 Information

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.

Company relocation benefits **will not** be provided for this position. For this position, you must reside in **or** within commuting distance to Plymouth MN.

\#LI-PHI

It 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