Electrical Engineer - Medical Device

Advantage Technical; Irvine (CA); On-site; USD 83,000 - 96,000; Full time

Job summary

Advantage Technical is seeking an experienced Electrical Engineer to support integration of implantable medical device technologies at our Irvine site. This role focuses on executing electrical design remediation, product integration, testing, documentation, and compliance activities in a regulated environment.

The ideal candidate has hands-on testing experience, exposure to implantable devices, and will contribute to design verification, risk management, and cross-functional collaboration with

Qualifications

• Bachelor’s degree or higher in Electrical Engineering or related field; Electrical Engineering preferred.
• 4+ years of engineering experience with a bachelor’s degree, or 2+ years with a master’s degree.
• Experience working in a regulated industry.
• Strong electrical and/or systems engineering background.
• Experience developing and reviewing engineering design documentation.
• Strong technical problem-solving and critical-thinking skills.
• Excellent written and verbal communication skills.
• Strong collaboration skills and ability to work with senior engineers and cross-functional teams.
• Ability to travel up to 10%, primarily locally.

Responsibilities

• Identify gaps between acquired-company practices and SOPs, work instructions, and quality requirements.
• Develop and execute strategies to close compliance and documentation gaps.
• Support electrical design remediation and product design refinement activities.
• Prepare and update engineering specifications, test methods, validation documentation, and technical reports.
• Support medical device design verification and design acceptance testing.
• Contribute to design hazard analysis, FMEA, design controls, and risk management activities.
• Evaluate engineering processes, products, components, and equipment and recommend improvements.
• Communicate technical progress, risks, trade-offs, and recommendations to project leadership.
• Complete complex engineering assignments requiring new or improved methods and procedures.
• Create clear, concise technical documentation to support product integration and knowledge transfer.
• Collaborate with external partners and suppliers on specifications, qualification activities, and testing protocols.

Skills

Regulated environment

Electrical engineering

Electrical & systems engineering

Technical problem-solving

Written & verbal communication

Collaboration

Attention to detail

Travel up to 10%

Education

Bachelor's degree in Electrical Engineering or related

Master's degree in Electrical Engineering

Tools

LTspice

Altium

Job description

Electrical Engineer – Implantable Medical Devices

Location: Irvine, CA 92618

Work Arrangement: 100% Onsite

Pay Rate: Up to $70/hour

Assignment: Axonics Integration

Travel: Up to 10%, primarily local travel

Position Overview

We are seeking an experienced Electrical Engineer to support the integration of medical device technologies into systems and processes. This is a highly execution-focused role working closely with senior engineers on electrical design remediation, product integration, testing, documentation, and compliance activities.

The ideal candidate will have strong experience in a regulated environment, hands-on testing experience, and preferably direct exposure to implantable medical devices.

Key Responsibilities

• Identify gaps between acquired-company practices and work instructions, SOPs, and quality requirements.
• Develop and execute strategies to close compliance and documentation gaps.
• Support electrical design remediation and product design refinement activities.
• Prepare and update engineering specifications, test methods, validation documentation, and technical reports.
• Support medical device design verification and design acceptance testing.
• Contribute to design hazard analysis, FMEA, design controls, and risk management activities.
• Evaluate engineering processes, products, components, and equipment and recommend appropriate improvements.
• Communicate technical progress, risks, trade-offs, and recommendations to project leadership.
• Complete complex engineering assignments requiring new or improved methods and procedures.
• Create clear, concise technical documentation to support product integration and knowledge transfer.
• Collaborate with external partners and suppliers on component specifications, qualification activities, acceptance criteria, testing protocols, and quality requirements.
• Work closely with senior engineers and cross-functional teams to ensure successful integration of acquired medical device technology.

Required Qualifications

• Bachelor’s degree or higher in Electrical Engineering or a related engineering discipline; Electrical Engineering preferred.
• 4+ years of engineering experience with a bachelor’s degree, or 2+ years with a master’s degree.
• Experience working in a regulated industry.
• Strong electrical and/or systems engineering background.
• Experience developing and reviewing engineering design documentation.
• Strong technical problem-solving and critical-thinking skills.
• Ability to analyze technical information from multiple sources and develop sound conclusions and recommendations.
• Excellent written and verbal communication skills.
• Strong collaboration skills and ability to work effectively with senior engineers and cross-functional teams.
• High level of personal accountability, initiative, and attention to detail.
• Ability to travel up to 10%, primarily locally.

Highly Preferred Experience

• Medical device industry experience.
• Implantable medical device experience and hands-on testing experience.
• Experience with medical device Design Verification and Design Acceptance testing.
• Experience with test fixture design and implementation.
• Analog and digital circuit design experience.
• RF design and testing experience.
• Experience with LTspice or equivalent electrical simulation tools.
• Experience with Altium for schematic capture and PCB design.
• Familiarity with IEC 14708 / IEC 45502 active implantable medical device standards.
• Familiarity with IEC 60601 electrical medical equipment standards.

Key Must-Haves

• Local to the Los Angeles / Orange County, CA area
• Able to work 100% onsite in Irvine
• B.S. or higher in Electrical Engineering or related field
• Experience in a regulated environment
• Strong electrical/systems engineering and testing experience
• Strong technical documentation skills
• Excellent critical thinking, communication, and collaboration skills
• Implantable medical device experience and testing strongly preferred
• Authorized to work in the U.S. without current or future visa sponsorship