Program Manager

2 months ago


Boston, United States BRIOHEALTH SOLUTIONS INC Full time
Job DescriptionJob Description

BrioHealth Solutions Inc. is seeking a skilled and motivated individual to join our team as the Program Manager. In this unique and exciting leadership role, you will be responsible for leading 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 CH Biomedical systems/processes, and Project Management expertise in working with project managers to build and lead cross-functional, multi-geographic 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 and product development leader with a passion for developing cutting edge medical technologies that are designed with the patient in mind, we invite you to apply.

Responsibilities

Program 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 work flow 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.
  • Works with other functions to improve processes/procedures, remove hurdles, and resolve issues facing their project teams.
  • Leadership and Team Development:
  • Excellent ability to influence program 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 mentor colleagues and make critical judgments and decisions.

Requirements

  • Bachelor’s Degree in Engineering (master’s degree preferred or equivalent combination of education and experience) plus 10+ 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 required.

About BrioHealth Solutions

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.


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