R&D Technician, BrioHealth Solutions

 Job Description

The R&D Technician is an important role within our organization, focusing on supporting the research and development activities related to medical device innovation. Working closely with engineers, scientists, the R&D Technician assists in the design, testing, and validation of medical devices, ensuring compliance with industry standards and regulatory requirements. This role requires meticulous attention to detail, strong technical skills, and a commitment to quality and safety in all aspects of the R&D process.

Responsibilities

• Assist in the design and development of medical devices, including prototype fabrication, assembly, and testing, under the guidance of R&D engineers and scientists.
• Set up and operate specialized laboratory equipment and instrumentation required for medical device testing and evaluation.
• Conduct experiments and tests to assess the performance, reliability, and safety of medical devices, following established protocols and procedures.
• Collaborate with cross-functional teams to troubleshoot technical issues, identify root causes of problems, and propose solutions or design modifications.
• Participate in the collection and analysis of experimental data, documenting results accurately and maintaining detailed records.
• Support the validation and verification activities for medical device development, including test method validation, design verification testing, and process validation.
• Assist in the preparation and submission of regulatory documentation, including technical files, design history files, and regulatory submissions, ensuring compliance with applicable regulations and standards (e.g., FDA, ISO).
• Stay informed about advancements in medical device technology, industry trends, and regulatory requirements, and apply this knowledge to improve R&D practices and processes.
• Maintain a clean and organized laboratory environment, adhering to safety protocols and regulations for handling hazardous materials and biomedical waste.
• Support the transfer of R&D projects to manufacturing, providing technical assistance and documentation to ensure successful production scale-up and commercialization.
• Participate in team meetings, project reviews, and technical discussions, providing input and feedback to drive continuous improvement and innovation.

Desired Experience and Skills

• Associate or bachelor’s degree (or equivalent experience) in mechanical engineering technology, electrical engineering technology, or a related field.
• Minimum of 2 years experience in a research or development role within the medical device industry.
• Strong technical skills, with experience in prototype development, testing methodologies, and data analysis.
• Machining and machine tools experience (mills, lathes, drill press, etc.).
• Electronics assembly and testing familiarity (power supplies, oscilloscopes, soldering, etc.).
• Proficiency in using laboratory equipment, tools, and software applications for experimental work including data collection and analysis.
• Excellent communication and collaboration skills, with the ability to work effectively in a multidisciplinary team environment.
• Detail-oriented mindset with a commitment to accuracy, quality, and safety in all aspects of work.
• Ability to prioritize tasks, manage multiple projects simultaneously, and adapt to changing priorities in a fast-paced R&D environment.
• Strong problem-solving skills and a proactive approach to identifying and addressing technical challenges.
• Commitment to professional development and continuous learning in the field of medical device technology and innovation.

About BrioHealth Solutions Inc.

BrioHealth Solutions Inc., Inc. is an advanced medical device company dedicated to the research, development, and commercialization of a miniaturized implantable ventricular assist system (CH-VAD^®) featuring total magnetic suspension (TMS) for the treatment of end-stage chronic heart failure. With offices in the U.S. and China, we are growing our U.S. team in preparation for clinical studies and regulatory approval in the U.S. and Europe.