- Providing Software Quality leadership for New Product Introductions 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.
- Identifying, promoting, and supporting processes and tools for use in preventing software defects (e.g. tools for assessing code design robustness and performance metrics)
- Understanding of all aspects of the QMS related to Design Controls.
- Development and status reporting of Quality and Reliability metric during phase reviews.
- Participate in Design Verification Planning, Protocol Review, and Report Review.
- Provide Guidance on Quality aspects of PDLM Deliverables in addition to Design Verification/Validation.
- 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) required. Experience implementing and using Software quality metrics is a plus.
- Your skills include expert knowledge of IEC Software Development Life Cycle) required, IEC Usability) preferred; ISO 13485 & 14971 required. Knowledge of algorithm development and user interface is a plus. Cyber security 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 Office/Remote position.
- You're a technical expert with strong communication skills, and effective in a matrixed organization and cross-functional role. Minimal travel required (<5%).
- Learn more about our business.
- Discover our rich and exciting history.
- Learn more about our purpose.
- Read more about our employee benefits.
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Principal Software Design Assurance Engineer - Plymouth, United States - Philips
Description
Job Title
Principal Software Design Assurance EngineerJob Description
Principal Software Design Assurance Engineer (Plymouth, MN hybrid)
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:
You're the right fit if:
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.
If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
Philips Transparency Details
The pay range for this position is $96,850 to $200,256, annually. The actual base pay offered may vary 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.
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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/Disabled/Veteran and maintains a drug-free workplace.
