USA - Systems Engineer II

Coordinate and manage system design for one or more groups of related products to achieve program goals. Oversee product development process from gathering user needs to product launch, including maintenance and engineering support for existing products. Collaborate with Marketing, Sales, Service, Operations, Quality Assurance, and Regulatory Affairs to define product requirements and resolve product issues. Work with Engineering Project Management to define and scope projects; participate in project teams. Translate market needs into technical product requirements in partnership with Upstream Marketing. Lead technical team and ensure clear communication of technical requirements. Serve as owner of the Design History File (DHF), ensuring thorough documentation of technical product requirements. Create and manage system-level specifications and ensure usability requirements per IEC 62366. Lead risk management activities per IEC 14971. Coordinate and review design and system requirements to ensure alignment with market needs, serviceability, and manufacturability. Maintain DHF traceability, including verification and validation plans and compliance documentation. Harmonize requirements across similar products where possible. Ensure adequacy of user documentation, working with technical writers. Lead development and documentation of product systems architecture and systems-level design. Provide technical leadership to ensure project success in cost, quality, and schedule. Resolve competing constraints among engineering, manufacturing, regulatory, and marketing functions. Plan and execute system integration tasks to minimize issues during verification and validation. Document traceability from requirements to verification activities and design entities. Resolve systems-related technical issues using problem-solving tools. Act as lead integrator for the product, proactively identifying and resolving integration issues. Support and adhere to Baxter Quality Management system and quality audits. Maintain and update end product configurations as needed. Perform other duties as assigned.Essential Competencies Bachelor s degree in Electrical, Mechanical, Software, Biomedical Engineering, or related field (or equivalent experience). Minimum 3 years of relevant experience in system development, including requirements, risk, cybersecurity, usability, performance, and reliability management. Experience with tools/practices such as QFD, Pugh Matrix, CTQ, DFR, DFX. Experience in diagnostic cardiology or other medical device system development preferred. Agile product development experience preferred. Excellent communication, interpersonal, leadership, and organizational skills. Strong decision-making and influencing abilities; collaborative mindset. Fluent in English (oral and written). Ability to work independently, self-motivated, creative problem-solver. Strong proficiency in Office applications. Team player with excellent customer service skills. Strong time management and prioritization abilities; adaptable and flexible. Willingness to learn and expand knowledge base.