Clinical Engineer

The Opportunity

This position works out of our offices in St. Paul, MN or Plymouth, MN in the EP division. In Abbott’s Electrophysiology (EP) business, we are 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 Staff Clinical Engineer, you will be part of our EP product development team focused on delivering diagnostic, imaging, and ablation therapy catheters and EP capital equipment.

Your role will involve requirement development, testing, data analysis, validation testing, and serving as a clinical consultant on clinical workflows and risk evaluation documentation.

• Provide feedback and insight on clinical workflows and clinical use of EP products.
• Support development of risk management documentation.
• Design, conduct/supervise, and support bench and preclinical studies for product concept feasibility and formal regulatory submission.
• Plan, coordinate, and conduct empirical and experimental analysis. Organize and analyze data from experiments or design builds and write reports on results.
• Conduct research and prepare research tasks.
• Document work suitable for technical papers and patents.
• Participate in project design reviews and project planning. Track performance against plan. Develop plan in conjunction with technical supervisor.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Perform other related duties and responsibilities, on occasion, as assigned.

• Bachelors Degree in Biomedical Engineering, Electrical Engineering, a related engineering field or an equivalent combination of education and work experience.
• Masters Degree in a relevant discipline, including Biomedical Engineering, preferred.
• Minimum 8+ years relevant, progressively more responsible work experience in medical product development and/or a graduate degree with relevant project experience.
• Clinical EP experience as an industry EP field clinical support position with RCIS, RCES, CCDS, or CEPS certification; or, Design Validation and GLP study experience in the medical device industry.
• Demonstrated ability to apply an expert understanding of clinical application to issues in order to bring tasks to resolution within assigned projects. Demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs is required. Medical device industry experience preferred. Training and experience in manufacturing processes and methods preferred.
• Experience working in a broader enterprise/cross‑division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment, both as a team member and as an individual contributor in a fast‑paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communication skills with the ability to communicate at multiple levels in the organization.
  
  Multitasks, prioritizes and meets deadlines in a timely manner. Strong organizational and follow‑up skills, as well as attention to detail.
• Ability to travel approximately 10%, including internationally.

• Career development opportunities within a global company.
• Medical coverage through the Health Investment Plan (HIP) PPO medical plan.
• Excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement and study debt program.
• Recognized as a great place to work and a leader in workplace diversity.

The base pay for this position is $97,300.00 – $. In specific locations, the pay range may vary from the range posted.