Full-Time

Sr. Principal Software Quality Engineer

Confirmed live in the last 24 hours

Baxter International

Baxter International

10,001+ employees

Provides essential medical products and services

Biotechnology
Healthcare

Compensation Overview

$120k - $165kAnnually

+ Annual Incentive Bonus

Expert

No H1B Sponsorship

Bellevue, WA, USA

Requires a minimum number of days a week onsite.

Category
QA & Testing
Manual Testing
Quality Assurance
Required Skills
Agile
Machine Learning
Risk Management
Data Analysis
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.
Responsibilities
  • 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.
  • Follow documented procedures for all activities related to the Company’s Quality System.
  • Support other areas of the Quality System and perform other tasks as defined by Management.
  • Complete other duties as assigned.

Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals globally. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Company Stage

IPO

Total Funding

N/A

Headquarters

Deerfield, Illinois

Founded

1931

Simplify Jobs

Simplify's Take

What believers are saying

  • Baxter's investment in Medically Home aligns with the growing home healthcare market.
  • Rising demand for personalized medicine offers Baxter opportunities for targeted therapies.
  • Expansion in telehealth supports Baxter's integrated healthcare solutions strategy.

What critics are saying

  • Needle-free injection technology could disrupt Baxter's traditional injection-based therapies.
  • Shift to home healthcare may require Baxter to adapt its product offerings.
  • Growing digital health importance necessitates further investment from Baxter to stay competitive.

What makes Baxter International unique

  • Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.
  • Strong focus on patient-centric innovation sets Baxter apart in the healthcare industry.
  • Baxter's partnerships, like with Ayogo, leverage digital health for improved patient outcomes.

Help us improve and share your feedback! Did you find this helpful?

Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support