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 113,000 colleagues serve people in more than 160 countries.

Clinical Engineer II, R&D – Burlington, MA

Leading an active lifestyle is important to the many people we serve. In Abbott’s Heart Failure division, we’re advancing the treatment of heart disease through breakthrough medical technologies in heart failure, allowing people to restore their health and get on with their lives. 

Description

We are seeking a high caliber Clinical Engineer II to support product development efforts by performing clinical engineering tasks such as investigating, defining, analyzing, documenting, and testing activities associated with the development of heart failure devices. Clinical Engineering performs additional analyses and/or interviews to determine the requirements and constraints on the system and is accountable for resolving cross-functional issues. Work requires the application of theoretical principles, evaluation, ingenuity, and creative/analytical techniques.

Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We value people with great ideas who partner with others internally and externally to take action and accomplish goals.

Responsibilities include:

• Represent clinical engineering on heart failure product development projects.  Support product development efforts by performing clinical engineering tasks such as defining, investigating, analyzing, testing, and documenting activities associated with development of specific products
• Leverage clinical and product expertise to aid new concept and product development, define preferred embodiments of products, features, and algorithms, and evaluate compatibility of system components in clinical workflow scenarios
• Owns pre-defined tasks within a larger effort such as definition, development, or validation of a system or sub-system, and drive them to on-time, high quality completion
• Investigate and define clinical requirements for new devices and system features, drive integration of features into the existing clinical workflows, and facilitate the transition of these features into products through clinical review and evaluation
• Interact with project teams and functional groups to plan and execute feasibility studies, preclinical studies, data development and claims studies, technology assessments, concept studies, or benchmarking studies
• Develop expertise in the scientific, technical, medical, and clinical aspects of Abbott heart failure devices and features and the disease states they aim to treat
• Provide input to the risk management process, including risk brainstorming, identification of Patient Harms, and severity and probability assessments
• Develop and support preclinical evaluation protocols, data analysis, and reports.
• Contribute to the evaluation and validation of a specific subsystem, system, or product prior to submission
• Provide input into Clinical Evaluation Plans and Reports in support of the product throughout its lifecycle.
• Support all company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
• 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

Your experience(s), education, and knowledge will further expand Abbott’s marketplace success:

Required 

• Bachelor’s Degree in an Engineering discipline (Biomedical, Systems, Electrical, Mechanical, Software) or related discipline
• Minimum of 2 years of R&D experience in medical device development and/or other highly regulated industry. (Advanced degree may substitute for some experience.)
• Demonstrated ability to apply understanding of clinical applications to issues in order to bring tasks to resolution within assigned projects
• Demonstrated ability to effectively integrate information from varied disciplines including Engineering, Marketing, Clinical Affairs, and Regulatory Affairs
• Ability to work in a highly matrixed, geographically diverse, fast-paced business environment
• Ability to leverage and/or engage others to accomplish projects
• Ability to travel approximately up to 25%, including internationally

Preferred 

• Advanced level degree in an Engineering discipline (Biomedical, Systems, Electrical, Mechanical, Software) or related discipline
• Class III implantable medical device experience
• Strong interpersonal and communication skills (verbal, written, presentation), with ability to clearly communicate complex information across all levels of the organization
• Strong analytical, problem solving skills
• Meets deadlines in a timely manner