What are the responsibilities and job description for the Senior System Engineer position at BRIOHEALTH SOLUTIONS INC?
About Us
We are a global team of like-minded Med-Tech professionals focused on patient centric solutions in a collaborative environment leading to excellent outcomes. We have developed an advanced and unique heart failure therapy technology in the BrioVAD® Left Ventricular Assist System (LVAS). We are introducing the BrioVAD LVAS to Heart Failure clinicians for use with the large number of indicated and untreated patients who could benefit from chronic mechanical circulatory support. The initiation of our INNOVATE™ Trial in the US is only the beginning. We are building a team to develop advanced technology intended to further improve patient outcomes, increase therapy acceptance, and enabling chronic MCS therapy to be accessible to more patients across the globe.
Job Summary
BrioHealth Solutions is seeking a Senior System Engineer to join our R&D team. This role focuses on developing cutting-edge implantable heart pumps and mechanical circulatory support (MCS) technologies. You will play a critical role in advancing new products, enhancing existing solutions, and ensuring compliance with regulatory standards. As a key contributor, you will support clinical trials, verification testing, and regulatory submissions, collaborating with cross-functional teams to translate user needs into precise engineering requirements.
Responsibilities
- Lead systems engineering efforts for new product development and enhancements.
- Support the FDA clinical trial and PMA process for the BrioVAD system in the U.S.
- Work closely with stakeholders to document user needs and translate them into engineering requirements.
- Conduct verification testing and assist with regulatory submissions for MCS products.
- Participate in detailed design, development, and product introduction.
- Collaborate with internal design teams and foster cross-functional relationships.
- Prepare and maintain technical documentation, including engineering requirements, specifications, and test protocols.
Qualifications
- Proven experience in systems engineering within medical device development.
- Bachelor’s degree in Computer Science, Biomedical, Mechanical, or Electrical Engineering (advanced degree preferred).
- 5 years of experience in FDA and/or EU MDR-approved medical device development and testing.
- Hands-on experience writing and executing test protocols for regulatory approval.
- Strong knowledge of FDA regulations and industry standards, including 21 CFR 820, ISO 14971, and ISO 13485.
- Experience working with controlled documentation systems in regulated environments.
- Excellent interpersonal, communication, and technical writing skills.
