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

Experience owning 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
Ability to investigate and define clinical requirements for new product/feature development and facilitate 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
Skill in gathering and analyzing input requirements for medical devices, supporting instrumentation/service infrastructure, and translating them into specific system requirements/interface specifications
Proficiency 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
Knowledge of developing and directing preclinical evaluation protocols, data analysis, and reports
Ability to contribute to evaluation and validation of specific subsystems or projects, including feasibility studies, usability and human factors analyses, technology assessments, concept studies, benchmarking studies, or submission studies
Experience collaborating with other organizations such as engineering, regulatory, human factors, quality, marketing, etc
Familiarity with providing input to risk management files and Clinical Evaluation Reports to support products throughout their 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

Responsibilities

Own pre-defined tasks within a larger effort 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 the translation into new projects through clinical review and evaluation
Work with field and medical personnel to define benchmarks for evaluating the 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 them 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 collected from the field or research studies
Develop and direct preclinical evaluation protocols, data analysis, and reports
Contribute 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
Collaborate with other organizations within the company as needed: engineering, regulatory, human factors, quality, marketing, etc
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 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

Skills

R&D

Clinical Requirements

User Needs

Feature Definition

Validation

Product Development

Sub-system Development

Cardiac Rhythm Technologies

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