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Job Description
Fluxergy is a rapid growing biomedical start-up. With its roots in engineering, the company prides itself on being to able to critical think and solve problems pragmatically, from a modular and systems level approach. We believe that open and clear communication along with the ability to adapt to changing situations to be paramount to the success of the team that takes the initiative. The ideal candidate for this position should believe in these philosophies as well as be resourceful, trustworthy, and have a deep desire to constantly learn.
The Project Manager reports to the Sr. Director of Compliance and Development and is responsible for managing New Product Development and product improvements. The Project Manager shall direct, plan, execute, and manage the roadmap, established timelines, and provide guidance for projects to successfully drive the business forward through the agreed scope, cost, schedule and quality objectives. The Project Manager acts as the leader of operational disciplines to guarantee release of high-quality data, in close collaboration with the Director(s) of R&D.
Responsibilities
Manage and drive cross-functional programs from end-to-end
Responsible for project budget estimation, resource planning and monitoring and managing project within timeline
Actively manage program risks and associated issues to minimize impact to the success of the program
Liaise with Director(s) of RD on project requirements and deliverables and regulatory teams on regulatory requirements and deliverables.
Engage with manufacturing and procurement groups as part of core team to ensure timely manufacturing transfer of developed product.
Coordinate product sustainment development projects in association with technical services team
Presentation of project plans, development updates and deliverables to Sr. Director of Compliance and Development and executive team, project stakeholders and business associates.
Responsible for clear and concise reporting and escalation of project progress, risks, countermeasures and issues
Maintain visual management of project progress (master schedule and core team deliverables)
Maintain project documentation to standards required by quality management system (QMS)
Requirements
Experience in product development of medical devices involving HW, SW, Test and Integration
Track record in managing projects with regulatory requirements and 510K process
Ability to pro-actively identify project roadblocks and implement countermeasures on time to prevent project delays
Experience in managing cross functional teams as Core Team Leader
Experience
Experience in product development of medical devices involving HW, SW, Test and Integration preferably with RUO/Clinical applications is required
Track record in managing projects with regulatory requirements and 510K process – knowledge of ISO13485 preferred
Ability to pro-actively identify project roadblocks and implement countermeasures on time to prevent project delays
Experience in managing cross functional teams as Core Team Leader
Education
BS Degree (MS preferred) in Bioengineering, Biomedical, Biology, Engineer, or STEM related fields
PMP certification or similar preferred