Senior Design Assurance Engineer

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.

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 FME - As, Design FME - As 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 . years experience in Quality Assurance, including Quality systems, standards, metrics, and tools in medical device industry. Working knowledge of medical device regulations (FDA 21 CFR 80.820, FDA 21 CRF Part 11, ISO 13485, ISO 10993, ISO 14971, ISO 10555)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.

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