Sr. Software Systems Engineer

Role Overview

Join our dynamic team as a Senior 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 ecosystem Digital Applications group, ensuring we meet customer needs while adhering to the highest regulatory standards.

Responsibilities

• 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.
• Utilize AI (prompt engineering, agentic AI, AI extensions on existing tools, etc.) to implement rapid requirements and risk prototyping, while maintaining quality and accuracy.
• Provide guidance, mentorship, and technical leadership to a distributed R&D team, fostering a culture of innovation and excellence.
• Develop innovative technical solutions to complex software system challenges, delivering high-quality results within tight deadlines.
• Assist in establishing robust system and software architectures for digital applications, ensuring alignment with established design inputs.
• Ensure systems of systems and interoperability considerations are accounted for and represented in the architectures.
• 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.
• Write, maintain, and own system-level and software-level design inputs/requirements, ensuring compliance with established Quality Management Systems (QMS) and regulatory frameworks such as ISO 13485 and IEC 62304.
• Lead ISO 14971-based risk analysis activities, from identifying inherent hazards to implementing effective mitigation strategies.
• Collaborate with verification engineers to define test strategies for system and software verification and validation plans, utilizing requirement tracing methods.
• Conduct ad-hoc testing of in-development and developed software systems to ensure ongoing product quality.
• Enforce and support teams in executing Agile/Scrum planning, including estimating, scheduling, and completing committed tasks.
• Drive collaboration with internal and external stakeholders to enhance processes, practices, and technical mentorship, transforming software requirements into effective test architectures.
• Interface with manufacturing, field service, operations, and customer training staff throughout the design transfer process.
• Ensure that product complaints and issues are addressed promptly, with appropriate impact assessments on requirements and risks.
• Uphold compliance with the product development process and quality system standards.

Qualifications

• Bachelor’s degree in an engineering discipline with 3+ years of experience
• Proven experience with regulated products and connected systems in the medical devices/biotechnology industry
• Experience with cloud-based digital applications is preferred (e.g. SaaS/PaaS/IaaS environments with AWS/Azure or similar CSPs)
• Experience with implementing AI/ML paradigms in Digital Applications a plus
• 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
• Exceptional oral and written communication skills
• Strong documentation skills and experience in a regulated industry