The Senior Project Manager will serve as the project lead while effectively managing the planning, execution, control and evaluation of all aspects of the product development project. The Senior Project Manager ensures all technical milestones, quality, budget and time goals are met. The Senior Project Manager effectively manages the project team including Third Pole employees, external consultants and vendors by communicating project status to management, proactively identifying risks, proposing solutions, and providing resolution of project issues. This individual provides leadership to the project team on processes including product development process, project governance, development plans, Gantt charts, decision trees, project costing, and forecasting.

Responsibilities:

• The Project Manager ensures optimal execution against product development and commercialization goals
• Creates and manages to timelines, risks, project budgets and scenario analyses to support and positively impact decision making
• Leads multi-disciplinary project teams through demonstrating an in-depth knowledge of medical device product development, excellent interpersonal communication skills, leadership skills, self-confidence, and influencing skills
• Manages the project progress and may influence the allocation resources; escalates any issues, constraints and risks to management in a timely manner
• Generates DHF and Technical File/Design Dossier deliverables such as the Design and Development plan and conducts stage gate reviews
• Develops strong working relationships with functional leads and other stakeholders • Acts as primary point of contact with appropriate third-party development and manufacturing partners as needed
• Creates and maintains comprehensive project documentation
• Identifies and communicates gaps in resources and personnel required to achieve the project timelines and quality
• Establishes realistic and well managed timelines to surface delays and resource constraints with a clear critical path, and suitable feed-in buffers to prevent unexpected timeline slips
• Works in conjunction with the technical lead and design quality assurance to follow a risk-based approach to project management with frequent design reviews
• Challenges stated timelines and effort assumptions using her/his own development experience and documentation requirements of Class III product with Class C software and electronics

Requirements:

• An Engineering degree, with 8+ years of demonstrated experience delivering complex medical device product development projects from R&D to commercialization
• Deep understanding of the regulatory and quality requirements around medical device product development
• Experience in development of integrated (HW and SW) medical devices
• Experience in FDA Class IIb devices, FDA Class III is a plus
• Skilled at getting the best out of the team through influence, negotiation, facilitation and organizational engagement
• Solid organizational skills including attention to detail and multi-tasking skills
• Knowledge and expertise in the use of project management methodologies and tools, e.g. Microsoft Project, Excel etc.
• Experience in managing project updates and risk to management and project teams
• Flexible and can adapt quickly to the changing needs of the organization
• Strong communication skills, leadership skills and team building competencies
• Ability to make rational and timely decisions.

Job Type: Full-time

Pay: Up to $175,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Waltham, MA 02452: Reliably commute or planning to relocate before starting work (Required)

Experience:

• medical device industry: 8 years (Preferred)
• project management: 8 years (Preferred)
• class II medical device: 5 years (Preferred)
• class III medical device: 5 years (Preferred)

License/Certification:

• PMP (Preferred)

Work Location: In person

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