Program Manager II - Transfers

Forj Medical•Saint Paul, MN

10d

About The Position

Exceptional People. Hard Problems. Meaningful Careers. Big Impact. Nowhere else can you touch as many life-changing medical technologies. At Forj Medical, we work side by side with more than 100 medical device companies from startups to global giants to bring life-enhancing technologies to market. Working with us means solving hard problems with extraordinary people in a collaborative work environment. Join us. Job Summary: The Program Manager (PM) will lead cross-functional project teams with primary responsibility for planning and executing production line transfers, site transfers, and related manufacturing transition activities, including transfers to locations outside of the United States. The PM will remain accountable for achieving on-time, on-budget program execution. The PM is responsible for managing transfer-focused programs, aligning customer requirements, internal stakeholders, receiving sites, and sending sites. The PM may also manage product development activities as needed; however, the primary emphasis of the role is coordinating product line and site transfers. The PM will manage programs of varied scope and complexity, with a focus on manufacturing transfers, production line moves, and site-to-site transitions. Operating in a matrixed environment, the PM will interface with engineering, production, quality and regulatory partners, supply chain teams, facilities, IS, HR, Finance, and the Forj Medical leadership team.

Requirements

B.S. or M.S. required, preferably in a technical, engineering, operations, or related field; PMP certification a plus.
5-10 years’ experience project and program management
Experience leading production line transfers, manufacturing transfers, site transfers, or production ramp activities strongly preferred, including transfers involving multiple facilities or locations outside of the United States.
Demonstrated experience in stakeholder management
Experience in the contract engineering service business preferred.
Must be proficient in the use of MS Project/Planner to develop schedules, allocate resources, and establish program budgets.
Excellent verbal and written communications skills. Must be able to convey business and technical concepts to a diverse customer base and to internal technical teams in a clear and concise manner.
Knowledge of business and management principles involved in resource allocation, leadership techniques, production methods and coordination of teams with many disciplines ranging from management to staff to technicians.
Excellent independent work ethic and organizational skills.
Understanding of FDA, ISO 9001 and ISO 13485 required.
Must be authorized to work in the United States.

Nice To Haves

PMP certification a plus.
Experience with all phases of new product development, from concept through commercialization, preferred but not required.

Responsibilities

Lead production line and site transfer programs, including coordination of transfer strategy, stakeholder alignment, knowledge transfer, documentation readiness, equipment and process transition planning, validation support, training coordination, production ramp readiness, and post-transfer stabilization.
Develop and maintain program plans and communicate program status to customer(s) and internal teams.
With limited oversight, direct and coordinate program activities including schedule adherence, program budget, plan tracking, milestones, scope changes, design-to-cost objectives, production line transfer readiness, manufacturing transfer execution, site transfer planning, plan updates, and weekly team meetings while leading personnel responsible for specific functions throughout the life cycle phases of the program.
Coordinate cross-site and international transfer activities as required, ensuring clear communication across time zones, alignment of roles and responsibilities, and effective escalation of issues impacting schedule, quality, cost, customer commitments, or regulatory expectations.
Manage multiple transfer-focused programs, generally of medium size and complexity, and may also manage product development programs when required.
Lead cross-disciplinary teams in a matrix organization.
Responsible for control and communications of project/program level risks, issue management, and project quality.
With Engineering, identify and execute opportunities for continual process improvement in Forj Medical product development processes.
On occasion, identify creative opportunities to add value to individual customers’ programs and products and provide value for Forj Medical, beyond defined project scope and constraints.