Sr. R&D Electrical Systems Engineer (Med Device)

Title: Sr. R&D Electrical Systems Engineer

Length of Contract: 4-6 Months + possible extension

Location: Santa Clara, CA Onsite only.

Ideal Start Date: Targeting August 11 or August 18, 2025

Interviews: 2 rounds, 1 on 1 first round, panel second round (onsite if local and willing for second round)

True Timeslots: Tuesday July 29 1pm-3pm PST

Reason for Needing a consultant:

The client requires hands-on electrical engineering support to assist with ongoing troubleshooting and root cause analysis efforts as part of their systems design team. This need stems from active development and refinement of critical subsystems, with a focus on design validation and continuous improvement.

Position Overview

The Sr. R&D Electrical Engineer, Systems will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. This individual will support product testing, sub-system/component qualification and design, and serve on multiple cross-functional initiatives for projects ranging from concept through commercialization.

Essential Responsibilities

• Design, develop, and troubleshoot electro-mechanical products in full compliance with company Design Control procedures and regulatory requirements (FDA, ISO, MDD/MDR)
• Perform hands-on root cause analysis and troubleshooting of electronic systems
• Support circuit design, breadboarding, testing, and electrical characterization activities
• Prototype and evaluate proof-of-concept designs in simulated environments; iterate based on performance and design feedback
• Utilize Altium designer for circuit analysis and design updates (not a pure PCB layout role)
• Define and manage system-level design inputs; ensure proper subsystem/component development and execution
• Design and qualify fixtures and sub-systems for verification, bench testing, and manufacturing
• Plan and execute design verification testing, including compliance with IEC 60601-1, 60601-1-2, and other applicable medical device standards
• Develop and execute in-vitro, in-vivo, verification, and validation test protocols and reports
• Analyze, evaluate, and procure new materials and components to support development and operational goals
• Document work in lab notebooks and design records in accordance with applicable SOPs and Quality Systems
• Identify and manage relationships with suppliers to ensure timely delivery of quality components and services
• Collaborate cross-functionally with engineering, manufacturing, and quality teams from concept through commercialization and sustaining

Must Have Requirements

• Bachelor s degree in Electrical Engineering (Biomedical Engineering not accepted) with 8+ years of experience
• Strong understanding and hands-on experience with analog and digital circuit design, analysis, and component-level testing
• Proficiency with Altium or similar circuit design CAD tools --MUST
• Expertise in troubleshooting, characterization, and defining system-level design inputs
• Experience designing, assembling, and qualifying test fixtures for design verification, bench testing, and manufacturing support
• Strong knowledge of engineering materials, component selection, and design for reliability and manufacturability
• Working knowledge of IEC 60601-1, IEC 60601-1-2, and other relevant collateral standards
• Comfortable working cross-functionally in a collaborative lab environment

Preferred Requirements

• Experience with JAMA requirements management system preferred
• Experience with JIRA preferred