BrioHealth Solutions Inc., Inc. is seeking a skilled and motivated individual to join our team as Senior Project Manager. In this leadership role, you will be responsible for leading (and supporting) new product development (NPD) projects from initial concept, through development and verification/validation testing, into manufacturing, and product launch. You will utilize a wide variety of technical experience, an acquired understanding of BrioHealth Solutions systems/processes, and Project Management expertise in working with cross-functional project teams. This position will play a key role in the product lifecycle of the device and must be comfortable working with project teams, functional leadership, and stakeholders. The ideal candidate will be a strong solutions driver who bridges the gaps between business and technology with expertise in influence management, team building, and conflict resolution.

Join our team and play a pivotal role in shaping the success of our NPD programs. If you are a project management expert with a passion for developing cutting edge medical technologies that are designed with the patient in mind, we invite you to apply.

Project Management:

• Develop comprehensive project plans, including optimizing the plan by negotiating content based on priorities, risk, resource, budget, and timeframe constraints; manages project resources, timelines, and budgets.
• Ensures creation and maintenance of project documentation including design history files, status reports, meeting minutes, project schedules, changes, issues, phase-gate/design reviews, project workflow and presentations following internal design control requirements for small/medium-sized cross functional projects.
• Manages process to handle project needs (e.g., resource needs, schedule changes, budget increases, etc.).
• Determines & recommends trade-offs between projects and resources to resolve conflicts.
• Works with personnel across departments to resolve issues, as appropriate.

Leadership and Team Development:

• Excellent ability to influence project direction through demonstrated successes is required for satisfying internal and external customers.
• Foster a culture of high performance, collaboration, and continuous learning within the team.
• Leadership qualities must include the ability to make critical judgments and decisions.

• Bachelor’s degree in engineering (master’s degree preferred or equivalent combination of education and experience) plus 7 years of product development experience, spanning multiple technical disciplines (software, firmware, electronics, mechanical design, industrial design).
• Expected behavioral qualities include a positive outlook and affinity for teamwork, logic, innovation, initiative, influence, and self-sufficiency. Accountable for meeting quality, schedule, and cost goals are essential, as are dependability and adaptability.
• Excellent communication and stakeholder management abilities, with the capability to interact with individuals at all levels of the organization.
• Experience in a regulated industry (and especially knowledge of the FDA Quality System Regulation) is required. Hands-on experience with multiple project planning methodologies, including critical path or critical chain as well as familiarity with issues surrounding the design and production of medical electronics is advantageous.

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.