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Baxter International Inc. · 1 day ago

Principal Software Systems Engineer

Raleigh, NC

Full-time

Hybrid

Senior Level, Lead/Staff

$112K/yr - $154K/yr

3+ years exp

Baxter International Inc. is dedicated to redefining healthcare delivery and making a significant impact on people's lives. The Principal Software Systems Engineer will be responsible for developing innovative healthcare solutions within the Infusion Pump Platforms and connected Digital Applications group, ensuring compliance with regulatory standards while driving best practices in software systems development.

BiotechnologyClinical TrialsHealth CareMedical

No H1B

Responsibilities

Driving Best Practices : Implement and champion best practices in software systems development and product lifecycles, utilizing Agile PDLC/SDLC and Systems Engineering methodologies in collaboration with development and verification teams

Technical Leadership : Provide guidance, mentorship, and technical leadership to a distributed R&D team, fostering a culture of innovation and excellence

Complex Problem Solving : Develop innovative technical solutions to complex software system challenges, delivering high-quality results within tight deadlines

Architectural Contributions : Assist in establishing robust system and software architectures for digital applications, ensuring alignment with established design inputs

User Needs Translation : Identify and capture user needs for digital applications, translating them into functional and non-functional system requirements. Lead cross-functional teams to ensure these needs are effectively integrated into system requirements

Documentation and Compliance : Write, maintain, and own system-level and software-level design inputs/requirements, ensuring compliance with established Quality Management Systems (QMS) and regulatory frameworks. Work with established requirements and risk management SW tools, and develop subject matter expertise in these tools

Risk Management : Lead ISO 14971-based risk analysis activities, from identifying inherent hazards to implementing effective mitigation strategies

Verification and Validation : Collaborate with verification engineers to define test strategies for system and software verification and validation plans, utilizing requirement tracing methods

Hands-On Testing : Conduct ad-hoc testing of in-development and developed software systems to ensure ongoing product quality

Agile Execution : Enforce and support teams in executing Agile/Scrum planning, including estimating, scheduling, and completing committed tasks

Stakeholder Collaboration : Drive collaboration with internal and external stakeholders to enhance processes, practices, and technical mentorship, transforming software requirements into effective test architectures

Design Transfer Process : Interface with manufacturing, field service, operations, and customer training staff throughout the design transfer process

Issue Resolution : Lead/assist in technical investigations for field issues and product complaints, with appropriate impact assessments on requirements and risks

Compliance Assurance : Uphold compliance with the product development process and quality system standards

Qualification

Agile PDLC/SDLCRisk ManagementRequirements ManagementMedical Device ComplianceCloud-based ApplicationsElectro-mechanical DevicesComplex Problem SolvingTechnical LeadershipDocumentation SkillsCommunication Skills

Required

A Bachelor's degree in an engineering discipline with 5+ years of experience, or a Master's degree with 3+ years of experience

Proven experience with regulated products and connected systems in the medical devices/biotechnology industry preferred

Familiarity with electro-mechanical devices is preferred

Expertise in requirements management, risk management, and development in an Agile environment, including experience in creating and maintaining product backlogs

Knowledge of implementing and enforcing medical device cybersecurity design paradigms is a plus

Experience with cloud-based digital applications (e.g. SaaS/PaaS/IaaS environments with AWS/Azure or similar CSPs) is preferred

Exceptional oral and written communication skills

Strong documentation skills and experience in a regulated industry

Benefits

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), with the ability to purchase company stock at a discount

401(k) Retirement Savings Plan (RSP), with options for employee contributions and 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

Company

Baxter International Inc.

Glassdoor3.7

For nearly a century, we have delivered on our commitment to saving and sustaining the lives of patients, working alongside clinicians and providers around the world.

Founded in 1931

Deerfield, Illinois, USA

10001+ employees