Senior Clinical Engineer at Abbott

Sylmar, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Ability to own pre-defined tasks within larger efforts such as user need and feature definition, validation, or product development of a sub-system, driving them to on-time, high-quality completion
Experience investigating and defining clinical requirements for new product/feature development, facilitating translation into new projects through clinical review and evaluation
Capability to work with field and medical personnel to define benchmarks for evaluating clinical performance of products/features
Proficiency in gathering and analyzing input requirements for medical devices, supporting instrumentation/service infrastructure, and translating them into specific system requirements/interface specifications
Skill in identifying potential product enhancements and new product ideas by applying an analytical approach to understanding clinical needs of physicians and users
Experience simulating or testing aspects of new projects to evaluate prototypes, validate output against customers’ intended use requirements, and analyzing electrograms, diagnostic, or programming data from the field or research studies
Ability to develop and direct preclinical evaluation protocols, data analysis, and reports
Competence in contributing to evaluation and validation of specific subsystems or projects for feasibility studies, usability and human factors analyses, technology assessments, concept studies, benchmarking studies, or submission studies
Experience collaborating with other organizations within the company (e.g., engineering, regulatory, human factors, quality, marketing)
Knowledge to provide input to the risk management file and Clinical Evaluation Reports supporting the product lifecycle
Compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
Ability to maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Support for all Company initiatives, Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

Responsibilities

Own pre-defined tasks within larger efforts such as user need and feature definition, validation, or product development of a sub-system, and drive them to on-time, high-quality completion
Investigate and define clinical requirements for new product/feature development, and facilitate translation into new projects through clinical review and evaluation
Work with field and medical personnel to define benchmarks for evaluating clinical performance of products/features
Report significant progress and final findings of projects to management and product development staff
Gather and analyze input requirements for medical devices, supporting instrumentation/service infrastructure, and translate into specific system requirements/interface specifications
Identify potential product enhancements and new product ideas by applying an analytical approach to understanding clinical needs of physicians and users
Simulate or test aspects of new projects to evaluate prototypes and validate output as meeting customers’ intended use requirements; analyze electrograms, diagnostic or programming data from the field or research studies
Develop and direct preclinical evaluation protocols, data analysis, and reports
Contribute to evaluation and validation of specific subsystems or projects as necessary for feasibility studies, usability and human factors analyses, technology assessments, concept studies, benchmarking studies, or submission studies
Collaborate with other organizations within the company as needed (e.g., engineering, regulatory, human factors, quality, marketing)
Provide input to the risk management file and Clinical Evaluation Reports in support of the product throughout its lifecycle
Support all Company initiatives as identified by management and in support of QMS, EMS, and other regulatory requirements
Comply with 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 as assigned

Skills

Clinical Engineering

R&D

Product Development

Validation

User Needs Definition

Feature Definition

Clinical Requirements

Medical Devices

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees