- 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.
- 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.
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R&D Technician - Salt Lake City, United States - BRIOHEALTH SOLUTIONS INC
Description
Job Description
Job DescriptionR&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
Desired Experience and Skills
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.