Systems Engineer

We are seeking a highly skilled and detail-oriented Sr. Systems Engineer to lead systems engineering activities across our product development efforts. This person will be responsible for engineering and scientific DHF development, guiding internal R&D projects, and leading V&V efforts across the broader development team. While this role does not include direct people management, it does require strong cross-functional leadership to drive alignment across engineering, quality, regulatory, clinical, and other partner functions. The systems engineering function is responsible for helping prepare for international submissions and ensuring compliance with FDA requirements and applicable international standards., * Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or equivalent is required. \n

• 7+ years of engineering experience, including technology or product development responsibility in medical devices, along with at least 3 years of experience providing technical leadership on cross-functional teams. \n

• 3+ years of experience in systems engineering for multidisciplinary products involving software and hardware is required. \n

• Demonstrated ability to lead cross-functional alignment and drive execution without direct people management authority. \n

• Experience with development processes and technical documentation writing is required. \n

• Knowledge of and experience with software development and programming for tools and data analysis is required. \n, * Experience with design control, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA) and software version control

This role encompasses project planning, technical specification development, test and test tool development, workstream coordination, tracking progress across development and engineering teams, and development of DHF and DMR records.

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Your Responsibilities Will Include:

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• Understand customer needs and write specifications for the system and sub-systems. \n

• Collaborate with SMEs to define and document system architecture and top-level design. \n

• Support technical designers in their design activities and verify fit of the design to system requirements. \n

• Conduct and review scientific analysis of the system (physical, hardware, software, algorithms, sensors, etc.) and related engineering activities to validate simulations and system design. \n

• Lead cross-functional alignment to define system specifications, requirements, architecture, performance, and usability objectives. \n

• Plan and conduct system integration, proof-of-design testing, and system and sub-system verification and validation activities. \n

• Build simulations and models of system functions, and lead feasibility studies. \n

• Perform measurements, create engineering designs, develop plans, and maintain laboratory notebooks for all work. \n

• Conduct testing (bench, V&V, in vivo), develop and utilize test protocols, and generate written reports. \n

• Recommend and enforce design compliance with electrical standards for medical devices. \n

• Conduct software evaluations, reviews, and system analyses. \n

• Act as a liaison between external vendors and internal cross-functional teams. \n

• Travel to customer sites, domestic and international, to gather VOC, perform testing, and support troubleshooting activities. \n

• Communicate business-related issues or opportunities to management as appropriate. \n

• Ensure personal and company compliance with all federal, state, local, and company regulations, policies, and procedures. \n

• Perform other duties as assigned. \n

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