Manager, Systems Engineering

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to: Career development with an international company where you can grow the career you dream of. 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. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity 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. What You'll Work On 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. Required Qualifications 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. Travel requirement of 15-20%. Preferred Qualifications Masters degree. Experience developing class III medical devices Experience with Left Atrial Appendage closure devices, structural heart, or electrophysiology products. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews. The base pay for this position is $113,300.00 - $226,700.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY

Product Development

DIVISION

EP Electrophysiology

LOCATION

United States > Minnesota >

Plymouth :

5050 Nathan Lane

N ADDITIONAL LOCATIONS

WORK SHIFT:

Standard TRAVEL:

Yes, 15 % of the Time

MEDICAL SURVEILLANCE

No

SIGNIFICANT WORK ACTIVITIES

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link -

English:

http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link -

Espanol:

http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life's greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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