Project Manager, Operations
Ambu · Noblesville
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.
Ambu provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.