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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
[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]

Computer Technician

AbbtechIrvine, CA
[job_card.temporary]

ABBTECH Professional Resources and our partner Dell, are looking for.If you or someone you know is interested, please apply with your most updated resume and will follow up with you to make this a ...[internal_linking.show_more]

Principal Digital Hardware Engineer, FPGA & PCB Design

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]

Computer Science Instructor Pool-Part-Time

InsideHigherEdAnaheim, California, United States
[job_card.part_time]

Column Range: Column 1 – Column 3 (depending on education)Salary Range: $1391.Click Here For Current Adjunct Salary Schedules.Computer Science Instructor Pool-Part-Time.Do you strive to make a diff...[internal_linking.show_more]

 • [job_card.promoted]

Sr. Engineer II - Power Electronics Hardware

Karma AutomotiveIrvine, CA, USA
[job_card.full_time]

Engineer II – Power Electronics Hardware.Engineer II – Power Electronics Hardware.Examples of such modules are Inverters, Powertrain Control Module, Battery Management Module, DC-DC and AC-DC Conve...[internal_linking.show_more]

Technical Recruiter, Hardware

AndurilCosta 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]

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]

Computer/IT

TradeJobsWorkForce92623 Irvine, CA, US
[job_card.full_time]

Computer/IT Job Duties: Setting up hardware and installing and configure software and drivers.Maintaining and repairing technological equipment (e.Installing well-functioning LAN/WAN and oth...[internal_linking.show_more]

 • [job_card.promoted]

Robotics Hardware Engineer, Rapid Integration and Test

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, 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]

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]

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]

Computer Repair Technician

CellairisFullerton, California
[job_card.full_time]

Ability to diagnose, troubleshoot, and repair devices within an allotted time frame.Have dexterity to be able to use your hands with small tools and parts.Clear vision and the ability to follow ins...[internal_linking.show_more]

Computer Repair Technician

CellairisGarden Grove, California
[job_card.full_time]

Ability to diagnose, troubleshoot, and repair devices within an allotted time frame.Have dexterity to be able to use your hands with small tools and parts.Clear vision and the ability to follow ins...[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]

Principal Engineer-Design Verification (Wireless Protocol Hardware)

Microchip TechnologyIrvine, CA
[job_card.full_time]

Are you looking for a unique opportunity to be a part of something great? Want to join a 17,000-member team that works on the technology that powers the world around us? Looking for an atmosphere o...[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]

Computer Repair Technician

CellairisCosta Mesa, California
[job_card.full_time]

Ability to diagnose, troubleshoot, and repair devices within an allotted time frame.Have dexterity to be able to use your hands with small tools and parts.Clear vision and the ability to follow ins...[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).