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 109,000 colleagues serve people in more than 160 countries.
A healthy heart is essential to good health. That’s why we’re committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people’s health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
Our location in Sylmar, CA, currently has an opportunity for a Senior Clinical Engineer.
WHAT YOU’LL DO
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Owns pre-defined tasks within a larger effort such as user need and feature definition, validation or product development of a sub-system, and drives them to on-time, high quality completion.
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Investigates and defines clinical requirements for new product/feature development and facilitates the translation into new projects through clinical review and evaluation. Works with field and medical personnel to define the benchmarks for evaluating the clinical performance of these products/features.
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Reports significant progress and final findings of projects to management and product development staff in the company.
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Gathers and analyzes input requirements for medical devices, supporting instrumentation/service infrastructure, and translates these into specific system requirements/interface specifications.
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Identifying potential product enhancements and new product ideas by applying an analytical approach to understanding the clinical needs of physicians and users
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Simulates or tests aspects of new projects to evaluate prototypes and validate output as meeting customers’ intended use requirements; analyzes electrograms, diagnostic or programming data collected from the field or from research studies.
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Develops and directs preclinical evaluation protocols, data analysis, and reports
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Contributes to the evaluation and validation of a specific subsystem or project as necessary to conduct feasibility studies, usability and human factors analyses, technology assessments, concept studies, benchmarking studies, or submission studies.
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Collaborating with other organizations within the company as needed: engineering, regulatory, human factors, quality, marketing, etc
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Provides input to the risk management file and Clinical Evaluation Reports in support of the product throughout its lifecycle.
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Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
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Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
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Performs other related duties and responsibilities, on occasion, as assigned.
EDUCATION AND EXPERIENCE YOU’LL BRING
Required
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BS Degree in biomedical, mechanical, electrical, or similar field.
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Minimum 6 years of relevant work experience in medical product development or an equivalent combination of a graduate degree with relevant project experience.
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Demonstrated ability to apply understanding of clinical application to issues in order to bring tasks to resolution within assigned projects.
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Demonstrated ability to effectively integrate information from varied disciplines including Clinical Affairs, Engineering, Marketing and Regulatory Affairs.
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Strong analytical, problem solving skills
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Demonstrated leadership capability in team settings
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Experience working in a broader enterprise/cross-division business unit model preferred.
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Ability to work in a highly matrixed and geographically diverse business environment.
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Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
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Ability to leverage and/or engage others to accomplish projects.
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Strong verbal and written communication ability
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Meets deadlines in timely manner.
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Strong organizational and follow-up skills, as well as attention to detail.
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Ability to travel approximately 10%, including internationally.
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Ability to maintain regular and predictable attendance.
Preferred
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Master’s or Doctoral Degree in biomedical, mechanical, or electrical engineering, or biological or physical science or medicine
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Advanced credential in a relevant discipline/concentration, including Biomedical Engineering, preferred.
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Fluent in medical procedure terminology and sound knowledge of cardiac anatomy
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Medical device experience preferred
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
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Training and career development, with onboarding programs for new employees and tuition assistance
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Financial security through competitive compensation, incentives and retirement plans
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Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
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Paid time off
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401(k) retirement savings with a generous company match
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The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.