Project Manager for Medical Device Manufacturing Capital Projects
We are seeking an experienced Project Manager to lead and manage capital projects within a medical device manufacturing environment.
Key Responsibilities:
* Manage the full project lifecycle from initiation to close-out, including scope definition, budget development, scheduling, resource allocation, and risk management.
* Oversee the design, procurement, installation, and validation of capital equipment and facility modifications.
* Ensure projects adhere to relevant regulatory requirements (e.g., FDA, ISO 13485) and internal quality standards.
* Collaborate effectively with cross-functional teams including Engineering, Manufacturing, Quality, and Validation.
* Manage external vendors and contractors.
* Track project progress, report on key metrics, and proactively address potential issues.
* Develop and maintain project documentation.
Qualifications:
* Bachelor's degree in Engineering or a related technical field.
* Proven experience (5+ years) managing capital projects within the medical device or a similarly regulated industry.
* Strong understanding of GMP, regulatory compliance, and validation processes.
* Excellent project management, communication, and stakeholder management skills.
* Experience with equipment procurement, installation, and commissioning.
* Familiarity with cost control and budget management.
About GerTEK Project Management & Technical Services:
We provide expert project management and technical services to support medical device manufacturing capital projects. Our team is dedicated to delivering high-quality results on time and within budget.