Project Manager, Program ​/ Project Manager, Operations Manager

Summary of Position:

The Project Manager is responsible for leading all aspects of the development process for assigned development programs. The Project Manager (PM) provides leadership and works closely with other functional leaders in the company to scope, plan, manage, execute, and complete product development projects. The PM will ensure product quality, cost, and performance objectives are met within the defined project budget, schedule, and resource allocation plan.

The PM will lead the project through all elements of Design Control and Production Transfer, as described in ISO 13485 and the FDA QSR. On-site Operations responsibilities include ensuring that all needs related to operating the Vapo Cinci site are met, including maintenance, supplies, and visitor coordination.

Primary Responsibilities:

* Coordinate and lead a cross-functional team through the execution of new product development projects

* Lead team through project planning, including task/schedule development, resource allocation, & budget

* Ensure market needs and product requirements are identified, properly documented, and understood by all stakeholders early and throughout the development process

* Lead daily project team stands up and weekly project sub-team meetings to drive completion to timeline

* Develop and manage a project risk register for each project

* Develop and utilize a project dashboard to maintain visibility to schedule, COGS, and risks/mitigations

* Escalate issues as necessary to functional leadership; drive towards resolution

* Maintain the project Deliverables Matrix and support DHF creation/updates

* Provide routine program communication and management updates

* Schedule and lead the team through design review and stage gate exits, including material preparation and reporting

* Coordinate communication and direction to ensure the Vapo Cinci site operates effectively

* Required to develop ECOs and other project documentation

Knowledge, Years of Experience,

Education:

* Bachelor's Degree in Engineering or a related field

* 5+ years experience in R&D or QA with demonstrated competence on new product development for a medical device

* Demonstrated knowledge of Quality Systems, ISO 13485 and FDA QSR for Medical Devices

* Knowledge of Project Management fundamentals; PMI certification preferred (CAPM, PMP)

* Ability to lead through influence

* Ability to identify risks and develop executable mitigation strategies

* Demonstrated strength in cross-functional collaboration with ability to disagree without being disagreeable

* Knowledge of Standards applicable to Medical Device Safety Risk Management (ISO 14971, ISO 62304, IEC 60601-1:2005, etc.)

* Knowledge of key directives affecting medical devices (MDR, RoHS, REACH, WEEE, etc.)