Senior Systems Engineer

You will lead complex product development for infusion pump platforms and related systems.

Responsibilities

• Develop software solutions for infusion pump platforms and related systems.
• Translate user needs into clear system-level and software-level requirements.
• Decompose high-level system requirements into software subsystem requirements.
• Conduct and lead risk analysis (FMEA, hazard analysis) and mitigation planning.
• Drive verification and validation (V&V) strategy, planning, and execution.

Required Skills

• 10+ years of senior-level systems engineering experience.
• Strong software development background within medical devices or electro-mechanical systems.
• Proven experience with Agile Development, Sprint Planning, and Backlog Management.
• Expertise in risk analysis, system safety, and V&V planning.
• Experience working cross-functionally with engineering, clinical, manufacturing, and QA teams.
• Knowledge of medical device development standards and regulatory processes (e.g., FDA, IEC 62304).
• Demonstrated technical leadership and decision-making abilities.