Senior Project Manager-Medical Devices

Responsibilities

• Organize project activities, lead the project team, prioritize and delegate tasks to team members in adherence with timelines and budget requirements.
• Lead multi-year medical and drug delivery development projects consisting of electronic as well as disposable devices.
• Ensure project scope is maintained and/or manage out-of-scope requests.
• Forecast engineering resources for short/mid/long-term project needs.
• Generate financial and project reports for internal and external communication.
• Liaise with the client for routine project updates, build relationships with clients.
• Support Business Development through project timeline and budget preparation for new opportunities as well as project extensions.
• Facilitate internal and external project meetings.
• Grasp technical details with an ability to assist the team in decision-making.
• Manage ongoing project timelines and budgets.
• Maintain documents relating to the overall project (project plan, user needs, etc.). Ensure deliverables are being met and the customer is satisfied.
• Cook up vendor activities (suppliers, third-party labs, manufacturers, etc).
• Ensure team members comply with established QMS guidelines/procedures/work instructions.
• Act as a project coach for more junior project managers. Advise on projects.
• Mentor junior team members and engineering interns.
• Support company-wide project management objectives.
• Support the recruiting process by participating in interviews for the project management team.

Requirements

• BS in Engineering or 4-year technical degree.
• PMP Certification (preferred).
• Must be willing to work in the Durham office a minimum of 4 days a week.
• 8+ years of experience with 5+ years of experience as a Project Manager in Medical Devices.
• Knowledge of medical device regulations (FDA/ISO).
• Possess strong project management skills and can work alone or in teams.
• Strong writing skills and/or data analysis.
• Able to communicate effectively with customers and vendors in a technical capacity.
• Competent computer skills, including Excel and Word.

Personal Attributes

• Meets Gilero Core Values: Collaboration, Integrity, Innovation, Excellence.
• Comfortable and productive in a fast-paced, entrepreneurial environment.
• A self-starter seeking a career opportunity with potential for internal advancement, seeking responsibility for core activities, and providing high-quality service to internal and external clients.
• Commitment to excellence and quality service to external and internal customers.
• Commitment to established policies and procedures, while contributing to continuous improvements.