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 Requirements 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 Certifications & Qualifications 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 #J-18808-Ljbffr