Electrical Engineer

Senior Electrical Engineer – Compliance & Design Remediation

Location: Irvine, CA (Hybrid – 3 days onsite)

Pay Rate: $60/hr

Work Authorization: Must be authorized to work in the U.S. (no sponsorship available)

Project: Medical Device Integration & Compliance Initiative

Role Overview

A leading medical device manufacturer is seeking a Senior Electrical Engineer to support a major integration and compliance project involving an acquired implantable device technology. This role focuses on identifying compliance gaps, refining electrical design documentation, validating test methods, and ensuring alignment with corporate engineering standards and regulatory expectations.

The position requires strong technical judgment, hands‑on engineering capability, and the ability to communicate risks, trade‑offs, and progress to project leadership.

Key Responsibilities

• Identify gaps between the acquired technology and internal engineering standards, work instructions, and SOPs, and define strategies to close those gaps.
• Provide input on project goals, timelines, and deliverables, recommending revisions when necessary.
• Communicate progress, risks, and technical trade‑offs to project leadership with clear recommendations.
• Execute complex engineering assignments requiring new or refined techniques, ensuring smooth integration of implantable medical device technologies into the existing product portfolio.
• Perform electrical design remediation, product design refinement, specification development, test method validation, and technical report preparation.
• Evaluate the feasibility and soundness of alternative engineering approaches, processes, or equipment.
• Produce clear, concise, and compliant engineering documentation.

Required Qualifications

• Bachelor’s degree in Electrical Engineering.
• 4 years of engineering experience.
• Experience in the medical device industry.
• Hands‑on experience with implantable medical devices and related testing.
• Strong background in electrical and/or systems engineering design documentation.
• Demonstrated problem‑solving ability and attention to detail.
• Ability to synthesize technical inputs from multiple sources and make sound recommendations.
• Strong communication, collaboration, judgment, and critical‑thinking skills.
• High personal accountability and a strong bias for action.
• Ability to travel up to 10% (primarily local).

Preferred Qualifications

• Familiarity with IEC 14708 and ISO 45502 standards for active implantable medical devices.
• Familiarity with IEC 60601 standards for electrical medical equipment.
• Experience with Altium, LTspice, or similar tools.
• Experience with Design Verification and Design Acceptance testing for medical devices.
• Ability to build strong cross‑functional relationships and work effectively with external partners.