Senior Design Assurance Engineer
Philips Iberica SAU, San Diego, CA, United States
Job Title
Senior Design Assurance Engineer
Job Description
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
Review test data and ensure the required confidence and reliability is achieved using statistical expertise
Qualifications
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
Physical, cognitive and environmental job requirements can be performed with or without accommodation.
Benefits
Location: San Diego, CA. This is an office role.
Pay range: $123,000 to $243,400 annually. Potential additional compensation such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in the comprehensive Philips Total Rewards benefits program, including generous PTO, 401(k) (up to 7% match), HSA, stock purchase plan, education reimbursement and more.
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. The position requires residing or commuting within San Diego, CA.
EEO Statement
Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace.
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.
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Senior Design Assurance Engineer
Job Description
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
Review test data and ensure the required confidence and reliability is achieved using statistical expertise
Qualifications
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
Physical, cognitive and environmental job requirements can be performed with or without accommodation.
Benefits
Location: San Diego, CA. This is an office role.
Pay range: $123,000 to $243,400 annually. Potential additional compensation such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in the comprehensive Philips Total Rewards benefits program, including generous PTO, 401(k) (up to 7% match), HSA, stock purchase plan, education reimbursement and more.
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. The position requires residing or commuting within San Diego, CA.
EEO Statement
Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace.
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.
#J-18808-Ljbffr