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Senior Principal Software Quality Engineer

https://www.baxter.com/ Logo

Baxter

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Location:
United States , Raleigh

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Category:
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Contract Type:
Employment contract

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Salary:

120000.00 - 165000.00 USD / Year
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Job Description:

As a Senior Principal Software Quality Engineer at Baxter, you will play a critical role in ensuring that software and device products are designed, developed, verified, validated, and delivered to high quality and safety on assigned projects. You will support project teams on both the New Product Development and sustainment engineering processes and will also participate in Design Assurance improvement initiatives. The position involves a collaborative environment and a focus on continuous education and development.

Job Responsibility:

  • Responsible for all Design Assurance functions as a core team member on new product development (NPD) teams, ensuring the team complies with all portions of Design Control and related Quality System elements
  • Prepare and manage all Design Assurance required deliverables as well as support the remainder of the team in developing a quality product that meets regulatory requirements
  • Responsible for ensuring product development activities related to verification and validation are fully compliant to the quality system procedures
  • Assist in identification and mitigation of product or process-related risks

Requirements:

  • B.S. in Engineering or other technical degree required, preferably Computer Science/Engineering or Electronics/Electrical Engineering
  • Software Quality experience is highly sought, especially in the medical device industry
  • Knowledge of AAMI 62304 standard is valuable
  • Minimum 8 years of experience in medical device or other regulated technical industry (e.g., aerospace, automotive, defense) in a design/development/quality role or in a role closely connected to design/development/quality is required
  • Proven ability to perform and influence in cross-functional team environments and utilize effective interpersonal skills
  • 2+ years of Quality experience desired
  • Product Design experience may be considered in lieu of Quality Assurance experience
  • Software development experience in a regulated industry is desirable
  • Knowledge of software development lifecycle processes and standards required
  • Understanding of software development tools and methods for medical devices and/or other regulated industries desirable
  • Familiarity of Quality System Regulations, Medical Device Directive, and ISO Quality System Standards
  • Knowledge of 21 CFR 820.30, ISO13485, IEC62304 desirable
  • Knowledge of EN ISO 14971:2012
  • safety by design
  • Risk Management structure desirable

Nice to have:

  • 2+ years of Quality experience desired
  • Software development experience in a regulated industry is desirable
  • Understanding of software development tools and methods for medical devices and/or other regulated industries desirable
  • Knowledge of 21 CFR 820.30, ISO13485, IEC62304 desirable
  • Knowledge of EN ISO 14971:2012
  • safety by design
  • Risk Management structure desirable
What we offer:
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Health & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • Educational assistance programs
  • Paid holidays
  • 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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