San Francisco Bay Area, CA
Senior Program Manager
Los Gatos – CA
The Sr. Program Manager is mainly responsible for leading and managing development and manufacturing transfer of complex Class II and III medical devices.
- Leads and manages development and manufacturing transfer of complex Class 2 and 3 medical devices including active implants, implantable leads, surgical devices and external use devices.
- Generates and maintains detailed project plans, task lists and project risk registers that enable the team to execute activities based on well-defined prioritization.
- Manages cross-functional team assigned to the functional segment to ensure successful completion of program goals and milestones, and adequate utilization of resources.
- Tracks program health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders.
- Proactively anticipates program risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions.
- Creates and maintains Design History File per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements.
- Supports project team in establishing and maintaining product requirements and test plans.
- Contributes to development, quality and risk management activities, and acts as backup to engineers and technical staff on assigned programs as required.
- Serves as the principal contact with external customers. Coordinates and directs customer meetings and visits, and day-to-day customer communication.
- Manages internal resources to meet program goals and milestones. Works with internal management to ensure appropriate resources have been assigned.
- Assists business development team with definition of program scope, timeline, and budget to support preparation of proposals, quotations, and change orders for customers.
- Manages, mentors, and provides guidance to other program manager(s) in the functional group.
- Reliable, consistent, and punctual attendance is an essential function of the job.
- Other duties as assigned.
This is not a remote position.
An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
- Minimum BS in Biomedical / Mechanical / Electronics / Computer Engineering with at least 10 years of experience within the medical device industry.
- Minimum 5 years of experience in project / program management of medical device development.
- Experience with neuromodulation devices, active implant devices and/or implantable lead assemblies highly preferred.
- Demonstrated ability to lead medical device development programs from early-stage design through verification/validation, and transfer to production.
- Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control.
- Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents.
- Ability to condense and communicate complex technical ideas, project status and risks to internal and external stakeholders.
- Must have proficiency in MS Project and other MS Office software.
- Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral.