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Computer hardware engineer h1.location_city

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Computer hardware engineer • irvine ca

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Hardware Engineer

Markent PersonnelIrvine, CA
[job_card.permanent]

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]

Hardware Engineer

Broadcom Inc.USA, CA Irvine Alton Parkway Bldg 1
[job_card.full_time]

If you are a first time user, please create your candidate login account before you apply for a job.If you already have a Candidate Account, please Sign-In before you apply.Broadcom's Central Engin...[internal_linking.show_more]

R&D Engineer Hardware 4

Broadcom Inc.USA, CA Irvine Alton Parkway Bldg 2
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If you are a first time user, please create your candidate login account before you apply for a job.If you already have a Candidate Account, please Sign-In before you apply.Designs and develops har...[internal_linking.show_more]

QA Hardware Test Engineer I

Infinite PeripheralsIrvine, CA, US
[job_card.full_time]

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]

Product Manager - Hardware - 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]

Technical Recruiter, Hardware Jobs

Clearance JobsCosta Mesa, CA, 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]

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]

Senior Data Scientist / Computer Vision Scientist

U341 Alcon Research, LLC. CompanyLake Forest, California
[job_card.full_time]

At Alcon, we are driven by the meaningful work we do to help people see brilliantly.We innovate boldly, champion progress, and act with speed as the global leader in eye care.Here, you’ll be recogn...[internal_linking.show_more]

High School Computer Science Tutor(Bilingual Mandarin)

Novel PrepIrvine, CA, US
[job_card.part_time]

We are seeking passionate and knowledgeable Bilingual Mandarin High School Computer Science Instructors to join our academic team.The ideal candidates will possess a strong academic foundation and ...[internal_linking.show_more]

Hardware Design Engineer

eTeamIrvine, CA
[job_card.full_time]

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
[job_card.full_time]

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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MTS II, Hardware

PanasonicIrvine, CA, US
[job_card.full_time]

Our new global headquarters is conveniently located in Irvine, CA near John Wayne Airport in the Park Place development.For our onsite and hybrid employees you will be able to enjoy amenities such ...[internal_linking.show_more]

R&D Engineer Hardware

Broadcom Inc.USA, CA Irvine Alton Parkway Bldg 2
[job_card.full_time]

If you are a first time user, please create your candidate login account before you apply for a job.If you already have a Candidate Account, please Sign-In before you apply.Broadcom is looking for ...[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
[job_card.full_time]

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]

Senior Hardware Certification Design and Compliance Engineer

Schneider ElectricLake Forest, CA, US
[job_card.full_time]

The compensation range for this full-time position applies to candidates located within the United States.Our salary ranges are determined by reviewing roles of similar responsibility and level.Wit...[internal_linking.show_more]

Adjunct Faculty - Computer Science

Concordia University - Irvine CaIrvine, CA, USA
[job_card.full_time]
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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]

Hardware Engineer

Hardware Engineer

Markent PersonnelIrvine, CA
[job_card.30_days_ago]
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  • [job_card.permanent]
[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).