PROGRAM MANAGER POSITION SUMMARY:

The NPI Program Manager leads the cross-functional engineering team for new product introduction (NPI), coordinating all facets of development of complex assemblies, from project inception through hand-off to production. The Program Manager is responsible for organizing and meeting program goals and objectives, managing the program financials and project timelines, customer communication, and managing the overall program scope. This is an indirect leadership role with no direct reports.
Responsibilities:

PROGRAM MANAGER REQUIREMENTS:

• Associate’s Degree in related field
• 6+ years of experience in contract manufacturing, program management and/or engineering role
• Extensive experience with medical device contract manufacturing
• Experience managing numerous projects simultaneously using appropriate software tools (i.e. Excel or Microsoft Project) and professionally communicating project status to customers
• Understanding of Laser Processing and Assembly
• Knowledge of ISO 13485, and FDA regulations
• Complete understanding of MRP and DFM principles
• Experience with the CAPA system
• Ability to consistently achieve short and long-term business results
• Experience with root cause analysis, corrective actions, and preventative action
• Knowledge and experience with Lean Manufacturing
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint)

PROGRAM MANAGER PREFERRED REQUIREMENTS:

• Bachelor’s Degree in Engineering or related field
• PMP Certification

• Administer and manage customer programs through the NPI stage gate process to collect, organize, and meet customer requirements, detailing the program scope, schedule, budget, and quality expectations
• Ensure compliance with the company Quality Management System (QMS), policies and procedures, regulatory agency standards and guidelines, and customer specifications throughout the development cycle
• Build and maintain a positive working relationship with internal and external customers
• Direct and assume accountability for the actions and performance of the NPI cross-functional team. Facilitate teamwork between departments
• Create project plans/timelines and promote a sense of urgency to ensure successful commercial launch
• Understand manufacturing capabilities and capacity of the organization
• Understand manufacturing and engineering processes that relate to the medical device industry
• Support estimating efforts for company products and services
• Lead discussions with customers and internal teams on designs, troubleshooting and find cost-effective solutions
• Manage/facilitate transfers to production
• Communicate with customers to provide project plans, timelines, program risk assessment, and milestones on a routine basis
• Proactively recommends, promotes, and supports actions for implementing continuous improvement projects. Assists internal teams with cost reductions, root cause analysis, and corrective actions
• Work closely with Engineering, Operations/Production, Supply Chain, Scheduling, and Quality to meet or beat customer delivery dates and On-Time-Delivery (OTD) performance
• Work with Quality to facilitate customer required audits
• Supports S&OP planning for assigned programs and customers
  Qualifications: