At NTT DATA, we know that with the right people on board, anything is possible. The quality, integrity, and commitment of our employees have been key factors in our company''s growth and market presence. By hiring the best people and helping them grow both professionally and personally, we ensure a bright future for NTT DATA and for the people who work here.
For more than 25 years, NTT DATA Services have focused on impacting the core of your business operations with industry-leading outsourcing services and automation. With our industry-specific platforms, we deliver continuous value addition, and innovation that will improve your business outcomes. Outsourcing is not just a method of gaining a one-time cost advantage, but an effective strategy for gaining and maintaining competitive advantages when executed as part of an overall sourcing strategy.
NTT DATA''s Client is seeking a Senior Manufacturing Application Project Manager to lead Project Planning & Execution: Define project scope, goals, and deliverables in collaboration with senior management and stakeholders. Create comprehensive project plans, including resource allocation, milestones, and timelines.
Budget & Resource Management: Forecast requirements, manage project budgets, track expenses, and mitigate variances.
Team Leadership: Lead and motivate cross-functional teams, delegating tasks effectively to ensure accountability and high performance.
Risk Management: Proactively identify potential risks, issues, and bottlenecks, developing contingencies to resolve problems quickly.
Stakeholder Communication: Serve as the primary point of contact for stakeholders, providing regular status updates, reports, and performance metrics.
Quality Assurance & Closeout: Ensure all project deliverables meet quality standards and organizational goals. Conduct post-project evaluations to identify areas for future improvement
Compliance & Validation: Direct software validation processes, ensuring all MES applications adhere to FDA 21 CFR Part 11 (electronic records and signatures) and Good Automated Manufacturing Practice (GAMP) standards.
Shop Floor Integration: Manage the .NET-based software architecture connecting plant floor hardware (PLCs, SCADA) to enterprise-level ERPs to track production metrics and genealogy.
Cross-Functional Leadership: Lead software engineers, automation experts, and quality assurance teams through Agile or hybrid SDLC methodologies.
Risk Management: Enforce cybersecurity and data integrity protocols specific to medical manufacturing, maintaining audit trails for device history records (DHR).
Expected Qualifications
Technical Stack: Strong proficiency in C#, ASP.NET, .NET Core, SQL Server, and WPF or Blazor for HMI/dashboard development.
Domain Expertise: Direct experience managing MES implementations within Life Sciences or Medical Devices (Class II/III).
Certifications: PMP (Project Management Professional) or Certified Scrum Master (CSM), coupled with deep knowledge of Quality Management Systems (QMS).
Regulatory Knowledge: Familiarity with ISO 13485 and FDA design controls
Strict Validation (CSV): Computer Software Validation is mandatory. Every configuration must be meticulously documented and proven to perform as intended.
eDHR (Electronic Device History Records): Transitioning from paper records to an eDHR system, requiring deep coordination between IT, quality assurance, and manufacturing operators.
About NTT DATA Services:
NTT DATA Services is a recognized leader in IT and business services, including cloud, data and applications, headquartered in Texas. As part of NTT DATA, a $30 billion trusted global innovator with a combined global reach of over 80 countries, we help clients transform through business and technology consulting, industry and digital solutions, applications development and management, managed edge-to-cloud infrastructure services, BPO, systems integration and global data centers. We are committed to our clients'' long-term success. Visit nttdata.com or LinkedIn to learn more.
NTT DATA Services is an equal opportunity employer and considers all applicants without regarding to race, color, religion, citizenship, national origin, ancestry, age, sex, sexual orientation, gender identity, genetic information, physical or mental disability, veteran or marital status, or any other characteristic protected by law. We are committed to creating a diverse and inclusive environment for all employees. If you need assistance or an accommodation due to a disability, please inform your recruiter so that we may connect you with the appropriate team.
This position is eligible for company benefits that will depend on the nature of the role offered. Company benefits may include medical, dental, and vision insurance, flexible spending or health savings account, life, and AD&D insurance, short-and long-term disability coverage, paid time off, employee assistance, participation in a 401k program with company match, and additional voluntary or legally required benefits.