Project Manager, Operations
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Country/Region: United States
State:
Business Area:
Department: Manufacturing, Noblesville
Employment Type: Full-time
Req ID: 10649
Objective:The Project Manager is responsible for leading and executing automation, equipment, and smart manufacturing projects within a regulated medical device manufacturing environment. This role oversees projects from concept through implementation, validation, and operational handoff, ensuring on-time delivery, budget adherence, regulatory compliance, and achievement of business objectives. The Project Manager partners with cross-functional teams, suppliers, and stakeholders to develop and deploy innovative automation solutions that improve quality, efficiency, traceability, and manufacturing performance.
Responsibilities and Essential Functions:- Lead automation and equipment capital projects from concept development through installation, validation, and production readiness.
- Develop and manage project plans, timelines, budgets, resources, risks, and deliverables to ensure successful project execution.
- Coordinate cross-functional teams including Engineering, Manufacturing, Quality, Validation, Regulatory Affairs, Supply Chain, and Operations.
- Manage relationships with equipment manufacturers, system integrators, and external suppliers to ensure project requirements are met.
- Drive project governance by facilitating project reviews, status updates, risk assessments, and stakeholder communications.
- Track and report project performance, financial results, savings, return on investment, and key performance indicators (KPIs).
- Ensure projects are completed safely, within scope, on schedule, and within budget.
- Lead the implementation of automated manufacturing and assembly systems, including robotics, PLCs, machine vision systems, motion control technologies, and automated inspection equipment.
- Support deployment of smart manufacturing technologies, including Manufacturing Execution Systems (MES), SCADA platforms, Industrial Internet of Things (IIoT) solutions, and data analytics tools.
- Collaborate with engineering and manufacturing teams to identify automation opportunities that improve quality, throughput, traceability, and operational efficiency.
- Facilitate equipment design reviews, factory acceptance testing (FAT), site acceptance testing (SAT), installation, commissioning, and startup activities.
- Maintain oversight of engineering documentation, project records, specifications, procedures, and standard work.
- Ensure all projects comply with applicable regulatory and quality requirements, including FDA Quality System Regulations, ISO 13485, and internal quality standards.
- Oversee validation planning and execution activities, including IQ, OQ, and PQ protocols, ensuring validated systems are production-ready.
- Partner with Quality and Validation teams to support process validation, equipment qualification, and change control activities.
- Ensure project documentation is complete, accurate, and audit-ready.
- Champion Lean Manufacturing, Six Sigma, and continuous improvement initiatives throughout project execution.
- Promote Design for Manufacturability (DFM) and Design for Assembly (DFA) principles when implementing new technologies and processes.
- Identify opportunities to improve project management processes, manufacturing systems, and operational performance.
- Support strategic manufacturing initiatives and perform other duties as assigned.
Qualifications:- Bachelor's degree in Engineering, Manufacturing, Project Management, or a related technical field.
- Minimum 6-8 years of progressive project management experience in a manufacturing environment.
- Minimum 5 years of experience leading automation and equipment capital projects.
- Minimum 5 years of experience within the medical device industry, with direct involvement in automated manufacturing processes and equipment implementation.
- Demonstrated experience managing multiple projects simultaneously, including budgets, schedules, resources, and risk mitigation.
- Experience implementing automation technologies such as robotics, PLCs, vision systems, automated assembly equipment, and smart manufacturing solutions.
- Strong knowledge of project management methodologies and tools.
- Excellent verbal and written communication skills, including the ability to prepare complex reports, business presentations, and executive communications.
- Experience with medical device process validation, equipment qualification (IQ/OQ/PQ), and change management.
- Strong knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 13485, ISO 14971, and other applicable medical device regulations.
- Ability to speak, read, write, and understand English.
- Project Management Professional (PMP) certification or equivalent project management certification preferred.
- Experience with MES, SCADA, IIoT, data analytics, and Industry 4.0 technologies preferred.
- Lean Six Sigma Green Belt, Black Belt, or equivalent continuous improvement certification preferred.
- Bilingual in Spanish preferred.
