A manufacturing company is seeking a NPI Project Manager to join their team!

The NPI Project Manager is responsible for transferring products from middle to late design stages into production, including final stage engineering activities and manufacturing activities such as design for manufacturability/assembly review and subsequent design updates, test development, build process development and improvement, etc. You'll be responsible for meeting deliverables both related to delivering units (beta, preproduction, etc.) plus enabling Manufacturing Engineering and Operations to continue with steady-state Production they work to complete design transfer from R&D into Production.

Duties/ Responsibilities:

• Drive multiple complex, and ambiguous projects as NPI/NPD project lead in the mid-to-late stages of the design life cycle through to manufacturing with very little guidance
• Create and maintain project plans, schedules, and budgets involving internal and external teams and prioritize based on the overall business and technical objectives aka “Big Picture”
• Act as a liaison for multiple cross-functional stakeholder teams such as engineering, quality, regulatory, supply chain, operations, top management, and the customer
• Lead test fixture, process design, and development in a hands-on environment
• Hold projects accountable against Gener8’s phase gate design and development process
• Become and act as the SME/technical supervisor, tracking work orders + material procurement for engineering/NPI/NPD builds, troubleshooting, and enabling Operations to take over as the project transfers into steady-state Production
• Successfully negotiate difficult technical and logistic issues with highly cross-functional (quality, ops, engineering, regulatory) and senior stakeholders
• Develop and optimize manufacturing protocols and processes for instrumentation (Work Instructions, Test Instructions, etc.)
• Be the customer advocate by regularly providing the customer with status updates as projects go through the transfer process
• Work with the end customer and internal teams to scope, quote, and propose engineering activities (both new and additions to existing statements of work)

Education/Experience:

• Minimum BS in Engineering or Scientific discipline
• Strong multidisciplinary technical experience working on complex instrumentation
• Technical problem-solving skills with the ability to critically review design and debug issues.
• 3+ years broad product experience
• Medical device/ISO-13485 design transfer experience
• Knowledge of manufacturing, test, quality and reliability best practices
• Experience in personnel management, mentoring, evaluation, and resource planning
• Strong analytical, planning and organizational skills
• Strong interpersonal and communications skills (oral & written)
• Self-starter with ability to work independently under pressure and react quickly to changing priorities