Manager, Systems Engineering

Abbott • Plymouth, MN

23h • Onsite

About The Position

This position works out of our Plymouth, MN location in the EP division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Systems Engineering Manager, you’ll have the chance to lead and own the systems engineering function for a portfolio of Left Atrial Appendage (LAA) products, including implantable occluder devices, catheter‑based delivery systems, and supporting imaging/visualization technologies. This role is responsible for driving end‑to‑end system architecture, requirements development, verification and validation strategy, and lifecycle management to ensure safe, effective, and regulatory‑compliant products. The Manager will lead a team of systems engineers and collaborate cross‑functionally with R&D, Clinical, Regulatory, Quality, Manufacturing, and Marketing to deliver differentiated LAA solutions.

Requirements

• Bachelor’s Degree Engineering or related field.
• Minimum 12 years related work experience with a complete understanding of specified functional area.
• Strong knowledge of medical device regulations, design controls, and risk management standards.
• Experience with implantable cardiovascular devices, catheter‑based systems, or interventional imaging technologies.
• Proven ability to lead cross‑functional technical teams and manage complex, multi‑disciplinary system architectures.

Nice To Haves

• Masters degree.
• Experience developing class III medical devices
• Experience with Left Atrial Appendage closure devices, structural heart, or electrophysiology products.

Responsibilities

• Own overall system architecture and technical strategy for LAA occluders, delivery systems, and imaging platforms across the product lifecycle.
• Ensure alignment of customer, clinical, and regulatory needs with system‑level requirements and design solutions.
• Serve as the technical integrator across hardware, software, firmware, imaging, and clinical workflow elements.
• Lead development and management of user needs, system requirements, subsystem requirements, and interfaces.
• Drive risk management activities including hazard analysis, FMEA, and risk‑benefit assessment.
• Define and oversee system‑level verification and validation (V&V) strategies, including bench, preclinical, and clinical support testing.
• Partner with Clinical and Regulatory teams to support IDE, PMA/CE submissions, and post‑market surveillance activities.
• Ensure imaging and delivery system performance aligns with clinical workflow and physician usability expectations.
• Act as the primary systems interface between R&D, Quality, Regulatory, Manufacturing, Supply Chain, Medical Affairs, and Commercial teams.
• Support design for manufacturability, serviceability, and scalability.
• Provide technical leadership during design reviews, phase gate reviews, and executive updates.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees