Senior Design Assurance Engineer

Philips • San Diego, CA

10h • Onsite

About The Position

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.

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.
• US work authorization is a precondition of employment.
• For this position, you must reside in or within commuting distance to San Diego, CA.

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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees