Location(s): United States; Massachusetts; Westborough
About Us: GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry. GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Role Summary: The FlexFactory Hardware Project Leader is accountable for the manufacture of the customized FlexFactory & singleuse automated equipment assembly, ensuring that the following are met: quality requirements; optimized performance for the customer’s process, operation and facility design, layout and regional location; and design compliance.
Reviews and analyzes assumptions for the project regarding price/cost, technical parameters, external requirements and its complexity for CBS operation
Establishes plans based on order assumptions to carry out the project with responsible departments
Breakdowns cost tracking committed by each function to enable assumed margin or better
Identifies critical line/activities
Closes contact with Enterprise Solutions Project Manager (ES PM) to review and update project schedules and risks in project
Obtains approval from ES PM on key information according to project schedule
Tracks project activities and report status regularly to management and ES PM
Initiates corrective actions as required
Obtains ES PM approval for deviations to initial requirements
Reviews accumulated cost with Finance and estimates the final cost
Coordinates Factory Acceptance Test (FAT) with ES PM to meet customer agenda, activities and participation
Ensures FlexFactory documentation to support the ES project is provided as needed and indicated by the ES PM
Ensures shipment according to customer agreement
Monitors transportation, installation and IQ/OQ at customer site if needed
Summarizes end project
Quality Specific Goals: 1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position 2. Complete all planned Quality & Compliance training within the defined deadlines 3. Identify and report any quality or compliance concerns and take immediate corrective action as required 4. Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones 5. Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives
Qualifications/Requirements: 1. BS Degree in Computer Science, Mechanical, Electrical or Biomedical Engineering or equivalent (defined as a High School Diploma/GED and 4 years relevant work experience) 2. 4 years relevant project leadership experience 3. Demonstrated leadership of cross-functional project teams and an ability to drive project design plans to completion 4. Familiarity with ISO, FDA and other regulatory standards
Bachelor of Science, Engineering, Business or Bio-Medical degree with relevant technical mechanical/automation/engineering focus,
5 or more years of experience in Project Management capacity within the biotechnology industry.
Experience working with external customer contacts
Ability to communicate clearly and effectively, both verbally and in writing
Locations: United States; Massachusetts; Westborough
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