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:
- Bachelors 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.