Philips Principal Software Design Assurance Engineer 

United States, Minnesota 

914072150

Principal Software Design Assurance Engineer

Principal Software Design Assurance Engineer (Plymouth, MN)

The Principal Software Design Assurance Engineer will support the development, qualification, and commercialization of innovative, highly reliable, life changing medical devices and associated software.

Your role:

• Provide Software Quality leadership for New Product Introductions (NPIs) and Sustaining product development teams for stand-alone software projects (SaMD) as well as software-related aspects of complex medical systems.

• Supporting the creation and review of all medical device software documentation including Software Development Plans, Software Safety Classification, Software Design Verification test plans, regression plans, and associated test protocols and test reports, software issue tracking and resolution, cyber security assessments such as Data Protection, Privacy, and Security Assessments etc.
• Leading the creation and review of risk management files to include the risk management plan, product hazard analysis, FMEA’s, Risk Management Matrix, and Benefit Risk Determination.
• Ensuring Risk Management is effective utilizing feedback from validation, field service, post-market surveillance, manufacturing indications, CAPAs, HHAs, etc. Familiarity with ISO 14971, Risk management for medical devices and IEC 62304 Medical Device Software. Provide guidance on Quality aspects of PDLM Deliverables in addition to Design Verification/Validation.
• Identifying, promoting, and supporting processes and tools for use in preventing software defects (e.g. tools for assessing code design robustness and performance metrics). Participate in Design Verification Planning, Protocol Review, and Report Review.
• Understanding of all aspects of the QMS related to Design Controls. Development and status reporting of Quality and Reliability metrics during phase reviews.

You're the right fit if:

• You’ve acquired 7+ years of related experience in the medical device industry, preferably with software products (both embedded and standalone). Class 2 software medical device experience from conception to launch required. Experience with verification and validation (V&V) nice to have. Experience implementing and using Software quality metrics is a plus.
• Your skills include expert knowledge of IEC 62304 (Software Development Life Cycle) required, IEC 62366 (Usability) preferred; ISO 13485 & 14971 required. Knowledge of algorithm development and user interface is a plus. Cybersecurity experience preferred, not required. SaMD experience is a must have, Artificial intelligence and Machine Learning experience are a big plus.
• You have a bachelor’s degree or higher in a related field.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .
• You’re a technical expert with strong communication skills, and effective in a matrixed organization and cross-functional role. Minimal travel required (<5%).

How we work together

This is an office-based role.

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.

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The pay range for this position in Plymouth, MN is $109,515 to $187,740.

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.