Product Manager

Responsibilities

• Be the Voice of Operational Clarity to Customers
• Attend internal production reviews and gather performance data including On-Time Delivery, NCR status, schedule risks, and change notifications
• Organize and communicate updates to customers in a timely, accurate, and professional manner aligned with company messaging and business interests
• Schedule and lead recurring customer touchpoints, preparing materials using data provided by Operations
• Document customer feedback and route requests to the VP of Operations for prioritization and response
• Communicate capacity, delivery metrics, demand forecasts, and production changes requiring cross-functional leadership engagement
• Escalate production and quality issues to the VP of Operations and communicate resolution status to customers as directed
• Align Cross-Functional Execution
• Serve as the primary liaison between Project Management, Production, Quality, Regulatory, Engineering, and Supply Chain
• Translate customer and business requirements into manufacturing plans through structured communication
• Coordinate with Supply Chain to ensure material readiness and resolve constraints affecting production
• Support and track engineering change orders (ECOs) and product changes; relay updates to customers as directed by leadership
• Communicate customer observations related to product quality and manufacturability; route improvement opportunities appropriately
• Drive Production Readiness & Performance Visibility
• Support production readiness efforts for New Product Introduction (NPI), including coordination of documentation, tooling, and training status updates
• Monitor and analyze production performance metrics such as yield, throughput, First Pass Yield, quality trends, and delivery timelines
• Support dashboard development for Senior Leadership by gathering, formatting, and reporting key metrics
• Maintain and update product documentation including DMRs, BOMs, and work instructions in collaboration with Quality and Engineering
• Participate in internal and external audits supporting FDA (21 CFR Part 820), ISO 13485, and other regulatory requirements
• Operate Within a Quality-Driven System
• Follow the Quality System and all applicable SOPs included in the Training Matrix
• Maintain documentation accuracy and ensure regulatory compliance in all communications and reporting

• Bachelor's degree in Engineering, Life Sciences, Operations, or related field (or equivalent combination of education and experience)
• 3+ years of experience in medical device manufacturing, product management, or operations
• Strong understanding of regulated manufacturing environments
• Demonstrated success working cross-functionally from product development through production
• Strong knowledge of FDA QSR (21 CFR Part 820), ISO 13485, and related medical device regulations
• Ability to analyze production metrics and translate data into actionable insights
• Excellent written and verbal communication skills
• Strong organizational and multitasking abilities
• Experience with ERP/MRP systems is a plus
• Lean manufacturing or Six Sigma exposure is a plus
• Proficiency in Microsoft Office 365

• Bachelor's degree in Engineering
• Bachelor's degree in Life Sciences
• Bachelor's degree in Operations
• ISO 13485 certification
• FDA QSR (21 CFR Part 820) knowledge
• Lean manufacturing exposure
• Six Sigma exposure