Principal, System Requirements & Risk Management Engineer

Baxter • Raleigh, NC

53d • $112,000 - $154,000

About The Position

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. Your Role at Baxter This is where your work saves lives Join our dynamic team as a Principal Software Systems Engineer in the R&D/Software organization, where you will play a pivotal role in developing groundbreaking healthcare solutions. You will be at the forefront of new product development and sustaining activities within our Infusion Pump Platforms and connected Digital Applications group, ensuring we meet customer needs while adhering to the highest regulatory standards. If you are passionate about transforming healthcare technology and eager to make a significant impact, this is the opportunity for you!

Requirements

• A Bachelor's degree in an engineering discipline with 5+ years of experience, or a Master's degree with 3+ years of experience.
• Expertise in requirements management, risk management, and development in an Agile environment, including experience in creating and maintaining product backlogs.
• Exceptional oral and written communication skills.
• Strong documentation skills and experience in a regulated industry.

Nice To Haves

• Proven experience with regulated products and connected systems in the medical devices/biotechnology industry preferred.
• Familiarity with electro-mechanical devices is preferred.
• 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.

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.

Benefits

• Baxter offers comprehensive compensation and benefits packages for eligible roles.
• Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Number of Employees: 5,001-10,000 employees