Job Description

This role will be responsible for leading the commitments to product feature scoping, system architecture, design, and integration in both the novel, miniaturized Cardiac Rhythm Management product development space as well as SDD’s broader, platform-focused technology development initiatives. Fluency in supporting product realization throughout the full arc of life-cycle steps ranging from early concept work to formal project initiation; through the end of verification and validation will prove fundamental. Candidates will necessarily bring deep technical expertise and a complimentary track record of critical thinking, effective verbal and written communication, as well as the capacity to coordinate robust collaborative engagements with a variety of technical, end-user, and business-oriented stakeholders.

Responsibilities:

• Contextualizing patient and clinical use expectations to drive design inclusions and lasting development decisions; fostering product embodiments that meaningfully serve market and end-user needs
• Garnering/coordinating technical alignment across a wide variety of partners/customers/teams to determine and structure system design architectures and segment features across sub-systems
• Critical thinking to distill crucial design trade-offs and propose clean, path-forward technical solutions
• Pragmatic/rational support for broad-spectrum functional system risk analyses to ensure patient safety while, at the same time, sidelining, “gold-plated” design concept embodiments
• Timely reporting of technical status to management, program management, and sub-system teams in concise/routine/archivable manners through strong written/verbal/graphical communication skills [ Note : Candidates will need to submit a writing sample, inclusive of referenced visuals, for review]
• Crafting/managing technical documentation to ensure partnering sub-teams have clear input/guidance, inclusive of testable requirements, in the regulated/process-controlled Class III medical product space
• Algorithm development, especially in support of early-stage feature development explorations

Qualifications:

• BS Degree in an engineering discipline or related technical and/or life-science field
• 8+ years of experience as a Systems engineer working in accordance with ISO/IEC/IEEE 15288 [ Note : Stated explicitly, we are NOT seeking IT Systems Administrators/Engineers]
• 3+ years of experience in medical devices, aerospace/defenses, or other highly regulated industries.
• Demonstrable success in driving one or more strategic, multi-faceted projects to completion
• Experience with issue management (per ISO 14971 and IEC 62304 for those with medical device backgrounds), in the service of development work bug documentation/dispositioning
• Baseline computer programming skills, inclusive of the ability to review embedded software, digital logic, and hardware description language (HDL)

Additional Preferred Knowledge, Skills, Abilities:

• Degrees in electrical and/or systems engineering (especially Masters-level) are generally preferred
• Experience in active CRM therapy product development, especially with miniaturized device types
• Versed on Internationally Council on Systems Engineering (INCOSE) best practices
• System simulation experience (e.g., SysML, Python/MATLAB, ANSYS, AMD Vivado [formerly Xilinx], etc.)
• Familiarity with international standards relevant to product realization in the Class III medical product space especially in regard to relevant system requirements interfacing strategies
• Previous experience in leading task force investigational initiatives (e.g., helming of “tiger teams”)
• Versed on the Usability process as outlined in IEC 62366-1

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