Principal Systems Engineer

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 SDDs broader platformfocused technology development initiatives. Fluency in supporting product realization throughout the full arc of lifecycle 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 enduser and businessoriented stakeholders.

Responsibilities:

• Contextualizing patient and clinical use expectations to drive design inclusions and lasting development decisions; fostering product embodiments that meaningfully serve market and enduser needs
• Garnering/coordinating technical alignment across a wide variety of partners/customers/teams to determine and structure system design architectures and segment features across subsystems
• Critical thinking to distill crucial design tradeoffs and propose clean pathforward technical solutions
• Pragmatic/rational support for broadspectrum functional system risk analyses to ensure patient safety while at the same time sidelining goldplated design concept embodiments
• Timely reporting of technical status to management program management and subsystem teams in concise/routine/archivable manners through strong written/verbal/graphical communication skillsNote: Candidates will need to submit a writing sample inclusive of referenced visuals for review
• Crafting/managing technical documentation to ensure partnering subteams have clear input/guidance inclusive of testable requirements in the regulated/processcontrolled Class III medical product space
• Algorithm development especially in support of earlystage feature development explorations

Qualifications:

• BS Degree in an engineering discipline or related technical and/or lifescience 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 multifaceted 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 Masterslevel) 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 623661