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Senior Systems Engineer

$149.06k - $184.72k

Verathon Inc

Verathon is a global medical device company committed to being a trusted partner to our customers and advancing patient care through innovative Airway Management and Urology solutions. For more than 40 years, we have worked alongside healthcare professionals to understand their needs and deliver high-quality technologies that provide lasting clinical and economic value. Our portfolio includes leading GlideScope® video laryngoscopy and BFlex™ bronchoscopy solutions, BladderScan® bladder volume measurement, and a growing range of single-use Urology solutions. Behind our innovations is a diverse, global team united by a commitment to our customers, collaboration, and improving patient care. Verathon, a business unit of Roper Technologies, is headquartered in Bothell, Washington, with international subsidiaries in Canada, Europe, and Asia Pacific. Overview Verathon® is looking for a Senior Systems Engineer to become the newest member of our Urology R&D team located in Bothell, WA. This role is expected to work primarily on-site at our Bothell facility and will establish the system requirements and architecture for an exciting new endoscope program targeted at improving patient outcomes in a demanding urological procedure - offering the opportunity to shape a highly miniaturized, single-use device from concept through commercialization within Verathon's established NPD framework. The Senior Systems Engineer is responsible for defining and architecting the technical foundation of a new endoscope program from the ground up. This role demands strong hardware systems instincts: the ability to understand physical failure modes, translate clinical and dimensional constraints into rigorous hardware requirements, and define subsystem interfaces for a miniaturized, single-use device. The Senior Systems Engineer serves as the technical authority for system-level design decisions, and the primary interface between clinical, marketing, and engineering teams throughout the product development lifecycle, utilizing Verathon's NPD process and Quality Management System. Responsibilities Author system-level requirements grounded in a deep understanding of hardware design, physical constraints, and failure modes, ensuring stringent compliance with FDA and other regulatory bodies Define and document system architecture for a miniaturized endoscope platform, including mechanical, optical, and electrical subsystem interfaces and integration with an existing capital equipment console Lead hardware-focused FMEA and risk assessments, identifying physical failure modes and driving risk mitigations into design requirements Manage product requirements input and traceability using a requirements management tool (JAMA) Interact with clinical and marketing teams on development and translation of user and stakeholder inputs to system (product) requirements for use by development teams Effectively collaborate with engineers, program managers, marketing, and business leaders on system level issues Define verification strategies for hardware requirements, including acceptance criteria, test methods, and pass/fail criteria appropriate for a single-use device Serve as primary contact for system level designs across various stakeholder groups in the product development process Support change analyses from a hardware systems perspective, evaluating design change impacts on requirements, risk, and verification coverage Participate in project planning by providing timelines for systems deliverables, ensuring assigned tasks are completed on schedule Provide mentorship for junior engineers and review their work for accuracy and completeness Modify established Systems Engineering procedures and drive related continuous improvement initiatives Qualifications Bachelor of Science degree in Engineering or Applied Physics is required; Master’s preferred Excellent written and verbal communication skills with the ability to translate complex technical concepts for diverse audiences; strong interpersonal and collaboration skills to build effective working relationships across engineering, clinical, regulatory, and business teams 8+ years of technical product development Demonstrated experience developing hardware-focused system requirements and architecture for physical medical devices, including mechanical, electromechanical, or optical subsystems Experience translating tight physical and dimensional constraints into verifiable system and subsystem requirements Experience performing hardware risk analyses (FMEA, fault tree, hazard analysis) with the ability to reason about physical failure modes and their clinical consequences Experience in writing technical documentation Experience with Systems Engineering standards such as INCOSE; familiarity with single-use and sterilization requirements for medical devices is a plus Experience with Medical Device Development and Risk Management standards including ISO 13485, ISO 14971, and IEC 60601 is required; experience with sterilization standards (e.g. ISO 11135, ISO 11607) is preferred Ability to define project goals and delivery dates to meet deadlines in a fast-paced environment Ability to make independent decisions using sound judgment, engineering principles, and techniques Travel up to 15% of the time is required including out of country Experience with requirements management tools (JAMA preferred) and project management tools (JIRA); familiarity with Microsoft Suite and ERP Systems Salary range - $149,061 - $184,716 (Compensation will vary based on skills, experience and location; it is not typical to be hired at or above the top of the salary range). Full-time employees who are not on a commission plan are eligible for Verathon’s annual bonus plan based on company and individual performance. medical dental vision basic life insurance paid holidays paid time off 401(k) matching plan For more information, please visit our complete Benefits Summary at #J-18808-Ljbffr

Vacancy posted 14 hours ago
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