Lead Systems Engineer

Job Summary:

The Lead Systems Engineer, R&D, GSS is a key stakeholder in the development of complex, technically challenging products. This role delivers value by translating detailed understanding of user needs into comprehensive, verifiable requirements that define system level performance of a complex medical device. This individual leverages close ties with marketing and clinical partners to inform deep understanding of the problems to be solved and how they affect the user/patient.

This individual will also work closely with all functional development groups to guide design direction and ensure all subsystems interface as intended. This individual has wide-ranging experience and uses professional concepts and company objectives to resolve complicated issues in creative and effective ways.

Essential Duties and Responsibilities:

The individual may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

* Leads high level architectural discussions to conceptualize clinical workflow and design solutions.

* Develops simulation models and analysis tools in MATLAB/Simulink to characterize system behavior, validate algorithms, and inform design decisions.

* Ensures the product's design addresses the specific user requirements for every clinical role involved in a procedure, incorporating perspectives from all user groups.

* Ability to communicate to the team the tradeoffs between different design directions and their impact on all aspects of the system.

* Drives product definition documentation by collaborating with Marketing on user needs definition and authoring product requirements.

* Understands relationships between different levels of design inputs and outputs, and generates effective matrices to communicate/document those relationships.

* Employs sound engineering principles to understand internal interfaces within the system, their interdependencies, and their impact on product-level performance.

* Maintains a basic understanding of relevant standards for medical devices and their impact on design control elements (i.e., design inputs, V&V testing, risk management, etc.).

* Leads the creation of V&V plans/strategy and demonstrates exceptional judgment in selecting methods, techniques, and evaluation criteria to verify all system level requirements.

* Works closely with marketing and the technical teams to deliver product value and contribute to defining the platform / product roadmap.

* Maintains strong network and relationships with Marketing, Sales, PMO, Design Assurance, Regulatory Affairs, Clinical Affairs and other functional partners.

* May contribute to the intellectual property of the company through invention and patent applications.

Qualifications:

Education

* Preferred Minimum Technical Degree:
Bachelor's in Systems Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering

* Preferred Minimum Technical/Advanced Degree:
Master's Degree

Experience

* Preferred Minimum: 8+ Years

* Preferred Minimum Technical/Advanced Degree: 6+ Years with Master's Degree, 3+ Years with PhD

Skills

* Strong clinical and technical knowledge within the field minimally invasive surgery

* Ability to drive end-to-end system integration of electromechanical and SW subsystems, establishing verification-ready builds for DV execution

* Foundational experience integrating MBSE workflows with ALM tools to maintain bidirectional traceability between system models, requirements, hazard analysis across development lifecycle.

* Ability to develop technical specifications and test methods for which to verify them.

* Ability to understand user needs and ability to validate them.

* Detailed understanding of Design Controls within the New Product Development process

* Ability to steer decisions on product risk; understanding of risk management across portfolio

* Broad understanding of engineering principles and methodologies; knowledge and experience across engineering disciplines.

* Knowledge of embedded systems with ability to collaborate between hardware and software working groups

* Foundational Matlab and Python background.

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