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Sr. System Engineer
2 months ago
BrioHealth Solutions is seeking a Senior Systems Engineer to join its R&D team to support new product development, improvements on existing products, verification testing, and clinical trials of its current implantable heart pump BrioVAD and related mechanical circulatory support (MCS) technologies.
Reports to: VP of R&D, Systems Engineering
Responsibilities
- Contribute to Systems Engineering in the R&D department in the development of new products and improvements of existing products through concept, engineering design, verification testing, and regulatory approval.
- Support the conduct of the FDA clinical trial and PMA of the BrioVAD system in the USA.
- Interact with internal and external stakeholders to understand and document new product user needs. Translate user needs into engineering requirements for new products.
- Support verification testing and regulatory submission for related MCS products.
- Participate in the detailed design and development of new products related to the mission of BrioHealth Solutions.
- Work collaboratively with other internal design teams for new product development and introductions.
- Build cross-functional relationships across the organization where persuasive skills, negotiation skills, and considerable tact are required to gain support.
- Generate, review, and maintain product documents that consist of user needs, engineering requirements, specifications, test protocols, and verification & validation reports.
Requirements
- Demonstrated track record of Systems Engineering performance within medical device development teams.
- BS degree in Computer Science, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or closely related field. Advanced degree is a plus.
- 7+ years of experience related to development and testing of US FDA and/or EU MDR approved medical devices.
- Direct experience with writing test protocols and reports that have been successfully reviewed and approved by regulatory agencies as part of regulatory applications.
- Knowledge of FDA regulatory requirements and familiarity with the following standards is a plus: 21 CFR 820 Quality System Regulation; ISO 14971 Risk Management; ISO 13485 Quality Management System.
- Must have experience with controlled documentation systems typically used in FDA regulated product environments.
- Strong interpersonal, communication and technical writing skills, with ability to work in a dynamic, multi-lingual environment.
- Up to 25% travel.
BrioHealth Solutions is an advanced medical device company dedicated to the research, development, and commercialization of a miniaturized implantable ventricular assist system (BrioVAD) featuring total magnetic suspension (TMS) for the treatment of end-stage chronic heart failure. We are growing our U.S. team in preparation for clinical studies and regulatory approval in the U.S. and Europe. More information at www.briohealthsolutions.com.
