Sr. R&D Engineer

Abbott • St. Paul, MN

2d • $78,000 - $156,000 • Onsite

About The Position

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 Senior R&D Engineer (Software Integration) you'll have the chance to be a a critical technical contributor to building compelling products within Abbott’s Electrophysiology (EP) Division as part of the R&D organization. In this role, you will participate in the development and deployment of system and software architecture to support our development programs. Working with other integration engineers, you will be responsible for participating in the concept development, testing, and investigation of complex software applications which include signal processing, algorithms and visualization in a real-time environment. All this will happen in an environment which emphasizes a robust cybersecurity and patient privacy focus.

Requirements

• B.S. in Engineering or related discipline.
• 5+ years of software engineering design in an FDA or highly regulated environment.
• Advanced degree may substitute for years of experience.
• An understanding of software development, requirements, risk management, and software and system level testing for medical device development
• Excellent verbal and written communication skills, with ability to communicate to all levels of the organization
• Demonstrated knowledge and experience working with Python, C++
• Operating Systems: Linux
• Experience with MATLAB and Excel

Nice To Haves

• Master’s Degree in Engineering (Biomedical, Computer, Electrical, Computer Systems, or Software), or related discipline / Advanced degree may substitute for up years of experience
• Knowledge of 62304, FDA 21 CFR 820 Design Controls and IEC 60601 and other standards applicable to Class II and Class III medical devices
• Development/Process Tools: Jira, Perforce, MS Visual Studio
• Experience using and developing software emulators and test scripts used to emulate hardware to enable software testing
• Working knowledge of cardiac anatomy and electrophysiology
• Demonstrated ability to provide technical leadership and mentorship

Responsibilities

• Design, develop, execute, and document system and software-level testing studies that simulate human clinical procedures to evaluate and characterize performance of devices (software, firmware, hardware) used in cardiac electrophysiologic procedures.
• Perform testing with real and/or emulated hardware to identify software issues/bugs.
• Utilize principles of operation and design fundamentals of various medical devices including diagnostic and therapy-delivery catheters, cardiac mapping systems, therapy delivery modalities and hardware, and cardiac imaging techniques.
• Perform system-level testing with clinical users in a simulated human clinical environment to characterize design for unmet user needs and clinical risks.
• Interact with clinical experts to gain product feedback.
• Lead and participate in the software investigation process of products in the development and early launch phase including assessing, tracking, and documenting issues/software bugs, root cause, and work arounds using Agile project management tools.
• Analyze experimental and clinical data using various software tools including Excel, MATLAB, and Minitab.
• Contribute significantly to completion of various project activities, from definition, use cases, risk, identifying software functional requirements, design, implementation, code reviews, and final release according to medical device development processes.
• Work closely with cross-functional team, including design reviews with QA, RA, test engineers, hardware engineers, HFE to ensure the software & firmware design meets the product requirements, including safety, reliability, and useability.
• Be creative and innovative in the product development process.
• Responsible for understanding clinical workflows, physician needs, and physiology of various cardiac arrhythmias and treatment modalities, especially atrial fibrillation therapies to act as clinical expert during design phase.
• Interact with other engineers in the software team and cross-functionally to develop workflow tests for the software/system and identify defects prior to releasing the product
• Write technical protocols/reports with cross-functional approval to capture testing and results
• Be a leader for the software integration team and act as the team representative for core team and technical teams.
• Make, recommend, or justify critical technical decisions in product design. The decision should be based on broad investigation and testing.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level