Job Title: Program Manager
Job Number: 23261
Location: Boston, MA
Management of the development life cycle for medical devices with emphasis on timely execution to project plan to ensure compliance with corporate development and documentation standards, delivering projects on schedule and budget with acceptable risk profile. Leadership through all stages of design life cycle, including requirements generation, development, risk management, verification/validation, cross functional area planning, transfer to manufacturing, and post market surveillance. Planning of complex interrelated tasks and activities with use of scheduling tools linked to achieving stated corporate goals. Daily management and recommendations on resources required for completion of project tasks. Matrix management of internal as well as external resources for assigned projects.
The Program Manager is an integral member of the project team responsible for assisting in the direction, organization and control of projects and associated activities, under the direction of the CTO.
- Project management of the product development life cycle of state-of-the-art robotic systems per company product development and design control procedures and in accordance to risk management standards in support of submissions to various regulatory entities and commercialization.
- Management and coordination of internal and external resources enabling timely execution of the project plan. Generation of tasks for coordination of project activities, including design, development, testing, laboratory activities and demonstrations.
- Manage project budget.
- Participation as group facilitator and direct management and documentation of requirements, inputs, outputs, specifications and test protocols/reports in support of verification and validation activities.
- Provide direction to engineers in support of timely and accurate completion of project tasks and in accordance to company procedures.
- Contribute to documentation of project activities in design history file and technical file. Participate as well as conduct reviews per company design control process.
- Track project deliverables, present reports defining project progress, problems and solutions, communicate status across the team and organization.
- Contribute to streamlining and implementing process improvements.
- Oversee compliance to design control and product development process of active programs.
- Ensure project team activities and decisions are clearly communicated, documented and archived.
- Bachelor’s degree or higher, preferably in a science related field, and/or commensurate industry experience.
- Minimum 10 years of project management experience or management of significant project components preferably in the medical or technology industry.
- Minimum of 7 years of experience within the medical device industry and exposure to medical device development over multiple projects/life cycles.
- Experience with working in ISO 13485 and 21 CFR Part 820 compliant environments.
- Proven experience with design control process and management of sub-teams or significant project efforts.
- Proven capability to lead multi-person cross functional teams comprised of internal and external resources.
- Partner with technical lead to guide team and project effort through all phases of the product development life cycle including: input, design output, verification, validation, and transfer.
- Knowledge of aging, sterilization, and shipping on medical devices. Ability to work with service vendors to establish protocols and execute testing plans
- Small company and/or start-up experience is desired. Ability to work well in a fast-paced environment.