Senior Design Assurance Engineer

Philips•San Diego, CA

1d•Onsite

About The Position

Senior Design Assurance Engineer As a Design Assurance Quality Engineer, the primary responsibility will be to work within the Quality Management System (QMS) to support the Design Assurance process during the development of new medical devices. Under the direction of Design Assurance Management, you will apply company policy and procedures as well as regulatory requirements to analyze situations or data and draw conclusions. Your role: Understand the processes and intent of all aspects of the QMS related to Design Controls Create and update new product risk management deliverables including Risk Management Files, Risk Management Plans, Use FMEAs, Design FMEAs and Risk Management Reports Support broader Design Assurance initiatives such as EU MDR readiness and Risk Management Remediation Using engineering principles, analyze situations or data to identify gaps between project work product and the QMS Provide Design Assurance review of deliverables to assess for compliance with internal and external requirements Reviewing test data and ensuring the required confidence and reliability is achieved using statistical expertise You're the right fit if: Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent. 3+ years experience in Quality Assurance, including Quality systems, standards, metrics, and tools in medical device industry. Working knowledge of medical device regulations (FDA 21CFR80.820, FDA 21 CRF Part 11, ISO13485, ISO10993, ISO14971, ISO10555) Working knowledge of the new product design and development in a regulated environment; preferably medical device Working knowledge of the application of risk management; preferably to medical device development You are able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position. 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 San Diego, CA is $123,000 to $243,400 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 San Diego, CA. #LI-PHI This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success. It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations 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. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. Know Your Rights

Requirements

Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
3+ years experience in Quality Assurance, including Quality systems, standards, metrics, and tools in medical device industry.
Working knowledge of medical device regulations (FDA 21CFR80.820, FDA 21 CRF Part 11, ISO13485, ISO10993, ISO14971, ISO10555)
Working knowledge of the new product design and development in a regulated environment; preferably medical device
Working knowledge of the application of risk management; preferably to medical device development
You are able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.

Responsibilities

Understand the processes and intent of all aspects of the QMS related to Design Controls
Create and update new product risk management deliverables including Risk Management Files, Risk Management Plans, Use FMEAs, Design FMEAs and Risk Management Reports
Support broader Design Assurance initiatives such as EU MDR readiness and Risk Management Remediation
Using engineering principles, analyze situations or data to identify gaps between project work product and the QMS
Provide Design Assurance review of deliverables to assess for compliance with internal and external requirements
Reviewing test data and ensuring the required confidence and reliability is achieved using statistical expertise