Systems Engineer II

The Opportunity

This position works out of our Plymouth, MN location in the Electrophysiology division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies, allowing people to restore their health and get on with their lives.

As the Systems Engineer II you will be part of our Electrophysiology Systems Engineering team focused on Left Atrial Appendage Occlusion. This role will be focused on development of catheter-based devices and accessories but will also involve a range of responsibilities including but not limited to the development of system and subsystem requirements and architecture, anatomical analysis, model development, prototype design, and strong cross functional collaboration.

What You’ll Work On

• Develops strong understanding of customer requirements and design requirements.
• Analyze and translate stakeholder and clinical needs into system requirements.
• Develop, review, and maintain system architecture, including structural, behavioral, and dependability views.
• Decompose system requirements and allocate functions and performance to system elements.
• Lead or support system verification and validation planning and execution to confirm that the system meets its specified requirements (verification) and fulfills the needs of the intended users in the intended use environment (validation).
• Partner with Marketing, Product R&D, Preclinical, Design Assurance, Regulatory, and Verification teams to ensure design implementations satisfy requirements.
• Define and execute system characterization, integration, and performance evaluation activities.
• Interface with end users to keep design direction aligned with real-world needs and clinical workflows.
• Apply multidisciplinary engineering judgment to design, develop, integrate, and troubleshoot complex electrophysiology systems.
• Contribute to risk management, interface management, and configuration control activities as part of new product development programs.
• Write and submit intellectual property (patents)

Required Qualifications

• B.S. in Systems Engineering, Biomedical Engineering, Mechanical Engineering or related discipline.
• 2+ years of experience in an R&D or medical device environment (or equivalent systems engineering experience).
• Strong technical knowledge including a demonstrated ability to think critically, problem solve, communicate clearly both in spoken and written form, and work effectively in a collaborative team environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Experience with nitinol and/or catheter based devices and delivery systems.

Preferred Qualifications

• Demonstrated systems experience
• Experience applying structured systems engineering processes (requirements management, architecture definition, interface control, V&V).
• INCOSE ASEP/CSEP (or equivalent systems engineering certification) preferred.
• M.S. in Biomedical, Systems, Mechanical or related engineering discipline.
• Working knowledge of cardiac anatomy and electrophysiology.
• 3D CAD experience (Solidworks or similar)
• Applied statistics experience with tools such as Minitab or JM