Description
Company Overview
This is a unique opportunity to launch your career in systems engineering at a pivotal moment of growth. As demand accelerates, we’re entering an exciting phase where scaling smart, reliable systems is critical, and you can be part of building that foundation from the ground up.
At Huxley, we’re developing a category-defining diagnostic platform SANSA that brings together a wearable device, AI-powered cloud technology, and real-world medical workflows. Our work sits at the intersection of sleep medicine and cardiology, helping deliver meaningful insights that can improve patient outcomes.
Role Overview
In this role, you’ll work closely with experienced leaders and a team that has successfully built and scaled multiple companies. You’ll gain hands-on experience across systems, operations, and product development, learning how complex technologies come together and scale in the real world.
This is a great fit if you’re curious, proactive, and excited to learn by doing. You’ll have the chance to take ownership of real challenges, build practical skills quickly, and see the direct impact of your work as our product reaches more patients
Responsibilities
- Support product development documentation (requirements, risk, V&V matrices, product labeling)
- Execute V&V protocols for hardware, firmware, and system-level testing in accordance with regulatory standards
- Manage and coordinate outsourced testing and validation activities
- Support mechanical testing and design documentation using SolidWorks
- Assist with new product introduction to manufacturing, including process documentation and training
- Support root cause investigations and corrective actions for sustaining products
- Collaborate with cross-functional teams including Quality, Operations, and Regulatory
Requirements and Qualifications
Required:
- Bachelor’s degree in Engineering (Electrical, Biomedical, Mechanical, or related field)
- Strong communication, documentation, and organizational skills
- Proficiency with SolidWorks for mechanical design and drawing creation
- Proficiency in Python scripting for automation and data analysis
- Hands-on experience with oscilloscopes, multimeters, and circuit-level debugging
Nice to Have:
- 3+ years of experience in the regulated medical device industry
- Familiarity with FDA Class II/III requirements and standards such as ISO 13485, ISO 14971, IEC 60601, and IEC 62304
Additional Information
Visa sponsorship is not available for this position.
What Success Looks Like
- You come in with a strong foundation of medical device life cycle development and make an immediate impact.
- You execute urgently on projects and propose solutions when you encounter problems or inefficiencies.
90 Day Plan
- 0-14 days (Onboarding & Orientation)
- Onboard and train in Quality Management System
- Familiarize yourself with the Sansa product
- 14-30 days (Familiarity with Product & Processes)
- Complete all required onboarding training
- Review product development documents for the Sansa product
- Familiarize yourself with the teams and processes you will be supporting
- Get up to speed on ongoing projects you will be supporting
- 30-60 days (Learn & Support)
- Begin contributing to systems deliverables for ongoing projects
- Support ongoing testing and failure investigations
- 60-90 days (Independent Ownership)
- Independently execute tasks assigned across all relevant ongoing projects
- Take ownership of all pod-level testing (confirmatory testing of bug fixes and feature additions; verification testing at firmware, hardware, systems level)