Staff Systems Engineer

The Opportunity:

The engineer will be primarily working on the heart failure device portfolio, which remotely monitors changes in pulmonary artery (PA) pressure, an early indicator of the onset of worsening heart failure, to aid physicians in preventing worsening heart failure, lower heart failure mortality rates, and improve quality of life for our heart failure patients.  The role is responsible for driving systems engineering for a wide range of Heart Failure device products including implantable sensors, external reader systems used by clinicians and patients, mobile application software, and cloud-based web applications.  This person will help to drive and lead the development of new programs and next generation products, including system design and architecture, requirements definition and management, design documentation, and system testing, verification, and validation.

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.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Required Qualifications:

• 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

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