Sr. Principal Software Quality Engineer, Baxter

Baxter

Location:

United States, Bellevue

Category:

IT - Software Development

Contract Type:

Employment contract

Salary:

120000.00 - 165000.00 USD / Year

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Job Description:

In this role, you will partner with development teams and cross-functional stakeholders to support the development of design control, risk management, and compliance deliverables associated with new product development of medical device software, digital health products, cloud-based systems, and AI/ML algorithm-based products.

Job Responsibility:

Partner with development teams and cross-functional stakeholders to provide technical and strategic feedback associated with the development of medical device software (SaMD and SiMD), digital health products, cloud-based systems, AI/ML algorithms and cybersecurity aligned with applicable regulations, standards, and business needs
Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated design control documentation for medical device software
Responsible for quality oversight and approval of software product development plans, risk management, design inputs and outputs, verification and validation, and review of test planning, protocols, and reports
Lead activities for establishing, implementing, and maintaining medical device software Risk Management Files (RMF), including analyzing and evaluating risks, controlling identified risks, and monitoring the effectiveness of the risk control measures
Establish and cultivate positive relationships with cross-functional stakeholders and product development team members to optimize the success of development projects
Provide guidance on statistical methods and analyses for design verification and validation, including test method validation
Serve as the SME for software quality and collaborate with teams on code reviews, software security analysis, defect and vulnerability triage, creation and maintenance of sBOMs, etc., and lead implementation of best practices for software quality processes
Participate in design reviews to ensure the effective development, transfer, and maintenance of the product throughout the product lifecycle
Support the successful transfer and hyper-care phase of design and design modifications into production/field deployment
Support/lead non-product software assessments and qualification efforts
Lead changes to the Quality System based on new regulations, mentorship documents, industry standards, and observations
Own the resolution and timely closure of CAPAs as they relate to the design control process.

Requirements:

B.S./M.S. in relevant engineering field (e.g., biomedical, computer science, software, electrical, etc.) or equivalent scientific degree
Minimum of 10+ plus years of progressive Quality Engineering experience in the medical device industry with hands-on support for software development
Experience supporting development of medical device software (SaMD and SiMD), digital health products, cloud-based systems, and AI/ML algorithms
Experience supporting the development of design control and design history file documentation for medical device software from inception through successful Design Transfer
Experience supporting software development teams using Agile development methodologies including supporting iteration planning, execution, demonstrations, and retrospective activities
Experience in the deployment of quality engineering tools for design and process improvement
extensive knowledge of statistical tools and data analysis techniques
Strong verbal and written communication and presentation skills
Demonstrated interpersonal skills including strong negotiation skills
Excellent writing skills to develop clear and logical information and conclusions based on design documentation.

What we offer:

Comprehensive compensation and benefits packages
Medical and dental coverage starting on day one
Basic life insurance
Accident insurance
Short-term and long-term disability insurance
Business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan with company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
Childcare benefits.

Additional Information:

Job Posted:

March 20, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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Sr. Principal Software Quality Engineer