V&V Test Engineer

Position Overview

We are seeking a talented and motivated Senior V&V Test Engineer to join our team full-time at our Bay Area facility. This is an on-site position offering hands-on experience with cutting-edge medical device technology.

In this role, you will be a key contributor to the verification and validation (V&V) of the system, working closely with our multidisciplinary engineering and Quality teams. You will lead the V&V test plan along with hands-on execution of the V&V activities for the overall system and its different sub-systems, while also supporting documentation as we prepare for design freeze, OUS regulatory submission and first-in-human clinical deployment.

The ideal candidate thrives in dynamic startup environments, brings strong technical skills combined with a collaborative mindset, and is excited by the opportunity to make meaningful contributions to a product that will directly impact patient lives. This position offers the chance to shape the future of our technology and organization for the right individual.

Roles and Responsibilities

• Lead and execute the V&V test plan for the overall uLink system (implantable device and external device) and its various sub-systems

• Lead V&V test method (STM) development for various tests and draft test protocols for electrical and ultrasound system characterization

• Build various test setups for efficient, robust and scalable execution of V&V tests

• Hands-on execution of V&V testing, related troubleshooting and documentation (Test reports)

• Maintain thorough and accurate documentation of all V&V activities in accordance with our Quality Management System (QMS)

• Initiate and manage V&V testing programs with external testing service providers

• Support verification activities in preparation for OUS regulatory submissions

• Closely collaborate with R&D, manufacturing and Quality teams

• Participate in design reviews and technical discussions to advance the product toward clinical milestones as well as provide V&V inputs for device improvements

Required Qualifications

• B.S. in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field

• 2+ years of professional experience in the medical device industry or similarly regulated industry (aerospace, defense, etc.) working under a Quality Management System

• Demonstrated proficiency with electrical test equipment such as oscilloscopes, function generators, power supplies, and multimeters

• Hands-on experience with electromechanical prototyping and building test setups and fixtures

• Experience with MATLAB or Python for data analysis, algorithm development, test automation, or simulation

• Strong problem-solving skills and ability to work both independently and collaboratively

• Excellent communication skills and ability to document technical work clearly

Preferred Qualifications

• CAD proficiency, particularly with SolidWorks, for mechanical design and integration

• Experience with PC interface and control of electrical test equipment

• Familiarity with wireless powering and data communication systems

• Experience with ultrasound systems, acoustic sensors, or related technologies

• Background in digital signal processing or related analytical techniques

• Understanding of FDA regulations, ISO 13485, or design control requirements for medical devices

• Prior experience in a medical device startup or early-stage company environment

What We Offer

• Meaningful Impact on life-saving cardiac technology

• Growth Opportunity with increasing responsibility as we scale

• Collaborative Culture with experienced medical device professionals

• Competitive Compensation including equity participation and PTO

• Comprehensive Benefits including health, dental, and vision coverage

Location & Work Environment

This is a full-time, on-site position based in the Bay Area, California. Our collaborative work environment emphasizes hands-on development, rapid iteration, and close teamwork. While we value work-life balance, the fast-paced nature of startup development occasionally requires flexibility in working hours to meet critical milestones.

This position will require minimal travel outside of Bay Area, California.