The Senior Project Manager is responsible for overseeing the planning, implementation, and delivery of medical device development projects.  This role leads cross-functional teams to ensure projects are properly resourced, completed on time and within budget, and meet quality and regulatory requirements.  The Senior Project Manager builds and maintains strong client relationships and works closely with Senior Leadership to achieve bb7’s project and financial goals.

Key Responsibilities:

Proposal Coordination & Delivery

  • Collaborate with Business Development Managers to identify project opportunities, scope, technical requirements, and necessary resources
  • Facilitate proposal development for fixed bid and time and materials projects, working with technical team members and Finance to ensure accuracy and quality
  • Present proposals to clients discussing technical details related to scope, timeline, and budget

Project Management

  • Manage diverse projects from initial requirements development and product specifications through formal presentation of project deliverables
  • Plan, estimate, schedule, conduct, and coordinate the financial, technical, and resourcing aspects of projects
  • Lead and coach team members throughout project lifecycle, coordinating with managers to address performance and behavioral concerns
  • Conduct projects in accordance with the bb7 ISO 9001 and 13485 quality management system (QMS) processes
  • Develop, communicate, and implement risk mitigation strategies and corrective actions to keep projects on target

Client Relationship Management

  • Understand client’s goals and what they aim to accomplish and provide solutions on how bb7 can help them achieve their objectives
  • Manage client expectations through ongoing, proactive communication and adhering to terms, conditions, schedules, budgets, and requirements as outlined in proposals and contracts
  • Identify changes in project scope and its impact on the budget and schedule; prepare change orders and submit for client approval

EDUCATION & SKILLS:

  • Bachelor’s degree in Engineering required (electrical, software, or biomedical preferred)
  • 7+ years of medical device design experience
  • 3+ years of experience managing projects and cross-functional teams (mechanical, electrical and software engineering, industrial design, test engineering, etc.), including development of project plans, schedules, and budgets
  • Demonstrated ability to manage project finances related to cost estimation, labor resourcing, and gross profit margin
  • Expertise in medical device manufacturing to meet international regulatory requirements (e.g., CE mark, FDA listing)
  • Knowledge of international design and testing standards for medical devices (e.g., IEC 60601-1, 62304 and related collateral standards, ISO 14971)
  • Experience in the use of project management and design control practices and software
  • Exceptional written and oral communication skills with the ability to clearly present technical ideas in formal and informal settings
  • Prior experience in consulting preferred

applybb7 and its Clients are equal opportunity employers and do not discriminate in employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, veteran status, marital status, disability, age, membership in an employee organization, or any other classification protected by federal, state, or local law. We participate in E-Verify.