Dice is the leading career destination for tech experts at every stage of their careers. Our client, Compunnel Inc., is seeking the following. Apply via Dice today!

Job Summary We are seeking an experienced Senior Manufacturing Application Project Manager to lead complex Manufacturing Execution System (MES) initiatives within the Medical Devices and Life Sciences industry. This role requires expertise in project management, manufacturing applications, software validation, shop floor integration, and regulatory compliance. The successful candidate will oversee cross-functional teams, ensure project delivery within scope, schedule, and budget, and drive compliance with industry standards and regulatory requirements. Key Responsibilities Define project scope, objectives, and deliverables in collaboration with senior leadership and key stakeholders. Develop and manage detailed project plans, including timelines, milestones, resource allocation, and project deliverables. Lead the execution of MES-related initiatives using Agile, Scrum, Waterfall, or hybrid SDLC methodologies. Forecast project requirements and manage budgets effectively. Monitor project expenses, analyze variances, and implement corrective actions when necessary. Optimize resource utilization across cross-functional teams and project phases. Lead, mentor, and coordinate teams consisting of software engineers, automation specialists, quality assurance professionals, and business stakeholders. Delegate responsibilities effectively while ensuring accountability and high performance. Foster collaboration between IT, manufacturing, quality, and operational teams. Identify, assess, and mitigate project risks, issues, and bottlenecks. Ensure compliance with FDA 21 CFR Part 11, GAMP, ISO 13485, and other applicable regulatory standards. Enforce cybersecurity, data integrity, audit trail, and validation requirements. Serve as the primary point of contact for project stakeholders. Provide regular project status updates, executive reports, performance metrics, and risk assessments. Facilitate communication and alignment between business, IT, manufacturing, and quality teams. Oversee Computer System Validation (CSV) activities to ensure systems and configurations are properly documented and validated. Ensure all project deliverables meet quality standards and regulatory requirements. Conduct post-project reviews and identify opportunities for continuous improvement. Manage .NET-based manufacturing application architectures integrating: Manufacturing Execution Systems (MES) PLCs SCADA systems ERP platforms Enable production metric tracking, genealogy management, and electronic batch record capabilities. Support the implementation and adoption of Electronic Device History Records (eDHR) systems. Required Qualifications 7+ years of hands-on experience with: C# ASP.NET .NET Core SQL Server WPF or Blazor for dashboard and HMI development 5+ years of experience managing MES implementations within: Medical Devices Life Sciences Regulated manufacturing environments 5+ years of experience with shop floor automation and system integration. Experience integrating MES platforms with: PLCs SCADA systems ERP solutions Strong understanding of Quality Management Systems (QMS). Expertise in: FDA 21 CFR Part 11 GAMP (Good Automated Manufacturing Practice) ISO 13485 FDA Design Controls Hands-on experience with Computer System Validation (CSV). Experience implementing or supporting Electronic Device History Records (eDHR). Ability to work effectively in highly regulated environments with strict documentation and compliance requirements. Strong leadership, stakeholder management, communication, and project delivery skills. Excellent analytical, problem-solving, and decision-making abilities. Bilingual communication skills in English and Spanish. Preferred Qualifications Experience working with Agile, Scrum, or hybrid project delivery methodologies. Experience leading digital transformation or manufacturing modernization initiatives. Familiarity with cybersecurity practices and data integrity requirements within regulated manufacturing environments. Experience supporting Class II and Class III Medical Device manufacturing operations. Experience coordinating onsite manufacturing projects and plant operations. Ability to manage multiple complex projects in fast-paced production environments. Certifications Project Management Professional (PMP) Certification. Certified Scrum Master (CSM) Certification. Education: Bachelors Degree Certification: Project Management Professional (PMP) , Certified Scrum Master (CSM)