Hardware Test Engineer

$142,000 - $239,000/Yr

Sandboxaq - Palo Alto, CA

Full-time - Mid Level

Palo Alto, CA

About the position

As a Hardware Test Engineer at SandboxAQ, you will play a crucial role in developing and validating sensing systems for medical devices, specifically the CardiAQ™ device. This position involves cross-functional collaboration to ensure the devices meet performance requirements for FDA market clearance, focusing on high product quality to enhance cardiac emergency care.

Responsibilities

• Develop verification and validation test bench systems and automated frameworks for acceptance testing of devices within the regulated quality management system for FDA submission.
• Assemble and configure cardiac sensor hardware to stream useful data during various prototyping stages.
• Analyze signal processing pipeline outputs to identify hardware and platform issues, recommending iterations to the developing product.
• Collaborate with sensor physics, mechanical engineering, quality assurance, and clinical teams to develop calibration and validation experiments.
• Create dependable manufacturing hardware test fixtures and customized V&V test routines in Python to assess sensor and system performance throughout assembly.
• Determine root causes of failure modes for hardware components and systems, developing actionable plans for quality improvement.
• Become an expert operator of cardiac devices, understanding their performance margins and testing those margins reliably.

Requirements

• BS degree in biomedical, systems, or mechanical engineering, or a similar field.
• 6+ years in medtech product engineering, preferably with Class II or III regulated devices through market clearance studies.
• Proficient in configuring hardware sensor systems and developing automated Python routines for test data generation and analysis.
• Experienced in developing quality verification and validation test systems and processes for medtech products at subsystem and system levels.
• Technical familiarity with mechanical, electrical, human factors/usability, industrial design, quality, and systems engineering.

Nice-to-haves

• Experience with complex capital equipment, sensing, or robotic devices.
• Support for medtech product market clearance/approval applications.
• Experience assembling and testing hardware components in a regulated manufacturing environment.
• Collaboration with outsourced engineering resources and contract manufacturing partners.
• Experience in the design transfer to manufacturing phase of medtech product development.
• Familiarity with rapid-prototype hardware fabrication and associated toolsets like 3D printing, milling, machining.
• Cardiovascular device/cardiology experience, particularly in the electrophysiology of the heart.

Benefits

• Competitive salaries
• Stock options depending on employment type
• Generous learning opportunities
• Medical, dental, and vision insurance
• Family planning and fertility benefits
• Paid time off (PTO) including summer and winter breaks
• Financial wellness resources
• 401(k) plans