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Abbott · 3 weeks ago

Sr. Clinical Engineer

United States - Massachusetts - Burlington

Full-time

Onsite

Mid, Senior Level

$75K/yr - $151K/yr

5+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. They are seeking a Senior Engineer to support product development efforts in clinical engineering tasks related to heart failure devices, including investigation, analysis, and testing activities.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

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 address

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

Qualification

Biomedical EngineeringMedical Device DevelopmentClinical Applications ExpertiseRisk ManagementInterpersonal SkillsAnalytical SkillsProblem-Solving SkillsCommunication SkillsTeam Leadership

Required

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

Preferred

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