NPI Program Launch Manager

The NPI Program Launch Manager leads customer tooling, manufacturing, and new product introduction (NPI) programs from order receipt or concept through validation and production launch within the medical injection molding division. This role ensures programs meet customer, quality, cost, and delivery targets by coordinating cross-functional activities, managing internal and external resources, and serving as the central liaison between customers and internal teams.

The ideal candidate combines strong project management skills with technical understanding of injection molding, tooling, and manufacturing processes to deliver a seamless design-to-production transition while maintaining compliance with regulatory and customer standards.

Key Responsibilities

Program Management

• Plan, execute, and control tooling and NPI programs through all project phases, from design transfer through validation and production launch.
• Develop detailed project plans, budgets, schedules, and Gantt charts using Smartsheet or MS Project.
• Track progress, manage risks, and ensure programs meet customer, cost, quality, and delivery objectives.
• Manage engineering changes and maintain documentation accuracy in ERP and quality systems (IQMS, Epicor, or similar).
• Provide regular program status updates to leadership and customers.
• Lead lessons learned sessions and continuous improvement initiatives post-launch.

Cross-Functional Leadership

• Lead core cross-functional teams including Engineering, Tooling, Quality, Production, and Supply Chain.
• Coordinate DFM and DFA reviews to ensure manufacturability and design readiness.
• Oversee prototype builds, tooling design/build, and validation activities (IQ/OQ/PQ).
• Align manufacturing readiness with customer milestones and launch goals.
• Support make/buy decisions and ensure alignment between program objectives and operational capacity.

Customer & Supplier Interaction

• Serve as the primary point of contact for assigned customers throughout the program lifecycle.
• Conduct regular customer meetings, report progress, and proactively resolve issues impacting timing, quality, or cost.
• Coordinate supplier tool build schedules, design approvals, and prototype delivery.
• Maintain contracts, specifications, and program documentation for internal and external stakeholders.

Process & Quality Compliance

• Ensure all programs comply with ISO 13485, FDA, and customer-specific regulatory requirements.
• Partner with Quality and Regulatory teams to support validation, documentation, and corrective action plans.
• Participate in continuous improvement projects and post-project evaluations to enhance program execution.

Qualifications

• Bachelor's degree in Engineering, Manufacturing, Project Management, or related field (or equivalent experience).
• 3-7+ years of experience in program or project management within injection molding, medical device, or precision manufacturing.
• Strong technical understanding of tooling, molding, and manufacturing processes.
• Proficiency in project management software (Smartsheet, MS Project) and ERP systems (IQMS, Epicor preferred).
• Excellent leadership, communication, problem-solving, and organizational skills.
• PMP certification or equivalent experience preferred.

Core Competencies & Traits

• Technically proficient, process-driven, and results-oriented.
• Collaborative, customer-focused, and able to lead cross-functional teams effectively under tight timelines.
• Detail-oriented, organized, proactive, and accountable.
• Adaptable, motivated, and committed to continuous improvement.

Additional Information

• Travel: Up to 20%
• Physical Requirements: Must be able to navigate manufacturing areas as required