We are proud to be part of Texas Medical Center Innovation (TMCi), a premier life sciences hub fostering breakthrough technologies in healthcare. Our research and development efforts are supported by prestigious grants, as we prepare for clinical studies and regulatory submissions.
Position Overview
Vivifi Medical is seeking a highly motivated R&D Technician with experience in medical devices to support verification and validation (V&V) activities leading up to clinical studies. This is an onsite position at the Center for Device Innovation (CDI) at Texas Medical Center (TMC), where you will work closely with our engineering team to test, iterate, and refine our innovative device technology.
Key Responsibilities
- Assist in verification and validation (V&V) testing, including bench testing, mechanical and electrical evaluations, and preclinical studies.
- Support design verification protocols, test method development, and regulatory compliance efforts (ISO 13485, FDA, IEC standards).
- Execute testing procedures to assess device functionality, reliability, and safety.
- Document test results, data analysis, and findings in accordance with regulatory and quality system requirements.
- Collaborate with engineers, clinicians, and external partners to optimize device performance.
- Assist with prototyping, assembly, and troubleshooting of medical device components.
- Maintain lab equipment, test fixtures, and ensure compliance with Good Laboratory Practices (GLP).
- Participate in design reviews, risk assessments, and failure mode analysis (FMEA).
Qualifications & Skills
- Associate degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field (Bachelor’s degree is a plus but not required).
- 1-3 years of experience in medical device R&D, V&V, or product testing.
- Hands-on experience with mechanical and electrical testing of medical devices.
- Familiarity with FDA regulations, ISO 13485, IEC 60601-1, and design control processes.
- Proficiency in SolidWorks, MATLAB, LabVIEW, or similar tools is a plus.
- Ability to work in a fast-paced startup environment, managing multiple tasks efficiently.
Why Join Vivifi Medical?
- Be part of an innovative startup transforming urologic healthcare.
- Gain hands-on experience in cutting-edge medical device development.
- Work in a collaborative and dynamic environment at CDI in Texas Medical Center.
- Opportunity to contribute to clinical translation and regulatory pathways.
