Senior Principal Software Quality Engineer, Baxter

Senior Principal Software Quality Engineer

Baxter

Location:

United States, Raleigh

Category:

-

Contract Type:

Employment contract

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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