Sr. Clinical Engineer

Abbott

8d

About The Position

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 114,000 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 We are seeking an experienced, high caliber Senior Engineer 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. What You’ll Work On : 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 Investigate and define clinical and human factors 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 Plan and execute feasibility studies, pre-clinical testing, technology assessments, benchmarking, and concept evaluations to inform design decisions. Develop expertise in the scientific, technical, medical, and clinical aspects of Abbott heart failure devices and features and the disease states they adresss Contribute to the risk management process, including risk brainstorming, identification of Patient Harms, and severity and probability assessments Develop and lead clinical validation plans and activities, ensuring robust evidence for product performance and safety. Contribute to the evaluation and validation of a specific subsystem, system, or product prior to submission 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.

Requirements

• Bachelor’s Degree in an Engineering discipline (Biomedical, Systems, Electrical, Mechanical, Software) or related discipline
• Minimum of 5 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 an expert understanding of clinical applications to issues in order to bring tasks to resolution within assigned projects
• Demonstrated ability to effectively integrate information from to varied disciplines including Engineering, Marketing, Clinical Affairs, and Regulatory Affairs.
• Demonstrated leadership in team settings, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results

Nice To Haves

• Advanced level degree in an Engineering discipline (Biomedical, Systems, Electrical, Mechanical, Software) or related discipline
• Class III implantable medical device experience
• Demonstrated ability to apply understanding of clinical application to issues in order to bring tasks to resolution within assigned projects.
• Excellent 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
• Ability to leverage and/or engage others to accomplish projects
• Ability to work in a highly matrixed, geographically diverse, fast-paced business environment

Responsibilities

• 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
• Investigate and define clinical and human factors 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
• Plan and execute feasibility studies, pre-clinical testing, technology assessments, benchmarking, and concept evaluations to inform design decisions.
• Develop expertise in the scientific, technical, medical, and clinical aspects of Abbott heart failure devices and features and the disease states they adresss
• Contribute to the risk management process, including risk brainstorming, identification of Patient Harms, and severity and probability assessments
• Develop and lead clinical validation plans and activities, ensuring robust evidence for product performance and safety.
• Contribute to the evaluation and validation of a specific subsystem, system, or product prior to submission
• 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.

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
• Number of Employees: 5,001-10,000 employees