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.