Staff Systems Engineer

Summary

Join our team as a Systems Engineer to drive systems engineering for Heart Failure device products, leading product definition, system architecture, requirements writing, and design control documentation.

Requirements

• Bachler’s Degree in Engineering (Mechanical, Computer, Electrical, or Software), Computer Science, or a related discipline
• 8+ years of in a similar position, including systems engineering and integration experience (integrating all system components - electrical, mechanical, software), system architecture, requirement/user need gathering, end-to-end (ideation to commercialization) technical product development experience, and/or system-level verification

Responsibilities

• Lead product definition, system architecture, requirements writing, requirements management, requirements analysis, risk analysis, System V&V, and design control documentation, from design conception to launch
• Participate in and drive systems level decision making, accounting for and prioritizing critical needs and requirements and assessing various options and solutions
• Gather, assess, and analyze needs and input from stakeholders and translates to system architecture, definition, and requirements
• Lead the planning of system engineering tasks including timelines, budgets, and prioritization
• Perform system level characterization of devices through development to refine requirements and finalize the design for System V&V
• Collect, organize, analyze, document, and present results
• Plan, execute, and/or lead System V&V testing, data analysis, and documentation
• Communicate effectively to cross-functional teams and senior management

Preferred Qualifications

• Advanced Degree in Engineering (Mechanical, Computer, Electrical, or Software), Computer Science, or related discipline
• Experience and expertise with systems consisting of hardware, software, mobile apps, and cloud components
• Experience and expertise with systems with RF, electromagnetics, ASICs, Bluetooth, and NFC technologies
• Class III implantable medical device experience, specifically supporting heart failure and/or cardiovascular systems and experience with biologic sensors (flow, pressure, EKG, etc)
• Strong knowledge of a development process consistent with ISO, FDA design control standards or requirements, and risk management practices
• Demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs
• Ability to work within a team and as an individual contributor and leader in a fast-paced, changing environment