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Computer hardware engineer h1.location_city

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Computer hardware engineer • orange ca

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Hardware Engineer

Markent PersonnelIrvine, CA
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This position is responsible for providing guidance on regulatory requirements as well as assisting in regulatory related projects and tasks ensuring compliance with FDA regulations, ISO standards,...[internal_linking.show_more]

QA Hardware Test Engineer I

Infinite PeripheralsIrvine, CA, US
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Join a growing team where your work matters! IPCMobile is looking for a QA Hardware Test Engineer I to help keep our operations running smoothly.This is a stable, full-time role with consistent wee...[internal_linking.show_more]

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Computer Science Instructor

American Straight A AcademyIrvine, CA, US
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American Straight A Academy (ASAA).Part-Time Remote High School Science Teachers Wanted.Join a fast-growing international online school delivering American high school education to students worldwi...[internal_linking.show_more]

Technical Recruiter, Hardware Jobs

Clearance JobsCosta Mesa, CA, United States
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Anduril Industries is a defense technology company with a mission to transform U.By bringing the expertise, technology, and business model of the 21st century's most innovative companies to the def...[internal_linking.show_more]

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Remote Computer Science Expert - AI Trainer ($75-$83 per hour)

MercorFullerton, California, US
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[job_card.part_time]

What you'll do**Author, review, and annotate technical tasks used to evaluate AI model performance on computer science problems.Tasks involve producing original problem sets grounded in architectur...[internal_linking.show_more]

Hardware Retail Sales Costa Mesa

Ganahl Lumber CoCosta Mesa, CA, US
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Ganahl Lumber Company is looking for a hardware sales employee to join our team in our Costa Mesa store.This person will actively seek out and engage customers to sell our product and/or services.T...[internal_linking.show_more]

Computer Vision Engineer, Maneuver Dominance

AndurilCosta Mesa, California, United States
[job_card.full_time]

Anduril Industries is a defense technology company with a mission to transform U.By bringing the expertise, technology, and business model of the 21st century’s most innovative companies to the def...[internal_linking.show_more]

Procurement Specialist- Hardware

ProponentBrea, CA, US
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Procurement Specialists typically liaise between suppliers and cross-functional internal teams in a fast-paced global work environment to ensure timely purchasing activities for an assigned vendor ...[internal_linking.show_more]

Procurement Specialist- Hardware

ProponentBrea, CA, United States
[job_card.full_time]

Procurement Specialists typically liaise between suppliers and cross-functional internal teams in a fast-paced global work environment to ensure timely purchasing activities for an assigned vendor ...[internal_linking.show_more]

Sr. Hardware Product Manager - Consumer Networking

TP-Link Systems Inc.Irvine, CA, US
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Headquartered in the United States, TP-Link Systems Inc.The company is committed to delivering innovative products that enhance people’s lives through faster, more reliable connectivity.With a comm...[internal_linking.show_more]

Hardware Design Engineer

eTeamIrvine, CA
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Role: RMA - Hardware Design Engineer.We’re seeking an Electrical Design Engineer to join our innovative team focused on building Electronics Control Unit (ECU) for Electric Vehicles.This is a high-...[internal_linking.show_more]

Computer Programmer

TradeJobsWorkForce92707 Santa Ana, CA, US
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Computer Programmer Job Duties: Code and test programming for software and mobile apps.Develop and deploy computer applications.Execute code builds to test and production environments.Collaborate w...[internal_linking.show_more]

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Remote Computer Science Expert - AI Trainer ($75-$83 per hour)

MercorStanton, California, US
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[job_card.part_time]

What you'll do**Author, review, and annotate technical tasks used to evaluate AI model performance on computer science problems.Tasks involve producing original problem sets grounded in architectur...[internal_linking.show_more]

Computer Science Part-Time Lecturer Pool

California State University, FullertonFullerton, CA, US
[job_card.full_time] +1

Department of Computer Science.The Department of Computer Science at CSU Fullerton invites applications for its Part-Time Lecturer Pool.We welcome applications from individuals who are passionate a...[internal_linking.show_more]

Senior Packaging Engineer, Electromechanical Hardware

AndurilCosta Mesa, California, United States
[job_card.full_time]

Anduril Industries is a defense technology company with a mission to transform U.By bringing the expertise, technology, and business model of the 21st century’s most innovative companies to the def...[internal_linking.show_more]

Lead Hardware Engineer, EagleEye Helmet

AndurilCosta Mesa, California, United States
[job_card.full_time]

Anduril Industries is a defense technology company with a mission to transform U.By bringing the expertise, technology, and business model of the 21st century’s most innovative companies to the def...[internal_linking.show_more]

Engineer II - Power Electronics Hardware

Karma AutomotiveIrvine, CA, USA
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Engineer II – Power Electronics Hardware.Engineer II – Power Electronics Hardware.Inverters, Powertrain Control Modules, Battery Management Modules, and both DC-DC and AC-DC Converters.Responsibili...[internal_linking.show_more]

Adjunct Faculty - Computer Science

Concordia University - Irvine CaIrvine, CA, USA
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The Computer Science Department at Concordia University Irvine seeks applicants for adjunct faculty.The department strives to develop wise and honorable citizens capable of excelling as witnesses o...[internal_linking.show_more]

Infrastructure Manager - Enterprise Hardware Asset Management (remote)

95-2566122 First American Title Insurance CoUSA, California, Santa Ana
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Join a team that puts its People First! Since 1889, First American (NYSE: FAF) has held an unwavering belief in its people.They are passionate about what they do, and we are equally passionate abou...[internal_linking.show_more]

Hardware Engineer

Hardware Engineer

Markent PersonnelIrvine, CA
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[job_card.job_description]

Job Title: Regulatory Affairs Specialist

Job Responsibilities:

This position is responsible for providing guidance on regulatory requirements as well as assisting in regulatory related projects and tasks ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies.

General Description and Duties:

To perform this job successfully, an individual must be able to perform each essential job task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Provides guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans to teams for solutions.
  • Represents regulatory affairs on product development and commercialization teams.
  • Ensures compliance with standards and execution of corrective actions and is the liaison with domestic and international customers and vendors.
  • Prepares and oversees documentation packages for submission to global regulatory agencies. Tracks timelines and documents milestone achievements for inclusion in regulatory submissions. Interacts with regulatory agencies as part of submission review and on-site audit support (e.g. IDEs, PMAs, annual reports, 510(k)s, STEDs, and CE marking design dossiers and technical files).
  • Assists with customer complaints/CAPA system.
  • Develops risk assessment review process for all marketed devices and implementation of changes to risk management process as needed.
  • Monitors proposed and current US and EU regulations and guidance and advises on the impact of such regulations.
  • Reviews documents for regulatory claims, promotional material, labeling content, product and process changes, and product documentation.
  • Collaborates and takes direction from RA management.

Projects and Other Duties:

  • Perform other duties as assigned.

Position Qualifications

  • Strong working knowledge of US and EU regulations that affect Class III medical devices.
  • Experience working on cross functional projects.
  • Fluent English with strong written and verbal communication skills.
  • Excellent analytical thinking and problem-solving skills.

Minimum Education:

  • Bachelor's degree in a related field, a scientific degree is preferred.

Minimum Experience:

  • 3 years of experience in a regulatory role or related area.

Salary:

Aligning our overall business objectives with performance and merit based pay, Our Client offers competitive salaries, performance-based incentives, and Employer paid benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $80,000 to $120,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).