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.

• 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.
• Review test data and ensure the required confidence and reliability is achieved using statistical expertise.

• 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 21
  
  CFR
  80.820, FDA 21 CRF Part 11, ISO
  13485, ISO
  10993, ISO
  14971, ISO
  10555).
• Working knowledge of 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.

This is an office role.

The pay range for this position in San Diego, CA is $123,000 to $143,400 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.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

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.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace.