Engineering Project Manager

Integra LifeSciences•Cincinnati, OH

31d•$62,000 - $85,000

About The Position

The Engineering Project Manager is responsible for the technical and leadership of the Integra's site facilities, utilities, equipment, and capital projects in manufacturing, laboratory, and non-manufacturing spaces of the site. They are responsible for multidisciplinary project definition through project hand off, including validation/commissioning, with the goal of optimizing asset life cycle management and sustainability by using good engineering practices in support of supply chain integrity. They ensure the planning and execution of their duties in compliance with corporate policies, U.S. Food and Drug Administration regulations, Good Manufacturing Practices (GMP), ISO 9001, ISO 13485, EU MDR, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.

Requirements

Bachelor’s degree in Engineering or a technical field with 5+ years of experience, including some leadership of projects or direct reports; or Master’s degree with 3+ years of relevant experience.
Strong organizational and communication skills (written and verbal).
Working knowledge of financial considerations related to projects, including budgets and cost impact of improvements.
Proficiency in Microsoft Office and familiarity with data analysis or statistical tools.
Experience in a regulated manufacturing environment (medical device or pharmaceutical preferred).
Basic knowledge of health, safety, and environmental regulations.
Self-motivated team player with the ability to work effectively both independently and collaboratively across functions.

Responsibilities

Promote a strong culture of safety by actively supporting environmental, health, and safety (EHS) programs.
Ensure team compliance with safety procedures, PPE usage, permits, housekeeping, and hazard awareness.
Participate in accident, near-miss, and incident investigations and support corrective actions.
Manage and execute site engineering projects, including product and process transfers, equipment qualifications, process validations, efficiency improvements, and resolution of quality and supply issues.
Supervise and support a team of engineers and technicians, including scheduling, training, daily operations coordination across shifts, and addressing operational challenges.
Contribute to performance management, employee development, and reporting of team results.
Support development and execution of engineering deliverables such as process requirements, specifications, drawings, engineering change orders (ECOs), CAPAs, and risk assessments (e.g., FMEA), as well as validation activities (IQ, OQ, PQ, PV, TMV, etc.).
Ensure project activities align with regulatory and quality requirements to maintain the safety, effectiveness, and reliability of medical devices, with a focus on patient safety.
Track and execute projects against defined timelines, budgets, and performance targets, supporting productivity and capital plan objectives for manufacturing and process equipment.
Collaborate with cross-functional teams and external contractors to implement projects, select equipment, and support facility or process improvements.
Monitor contractor progress against schedules, deliverables, and change controls; assist in documentation and handover activities, including as-built drawings and project records.
Perform other related duties as assigned.