Basic Functions:

With a minimum supervision, perform and coordinate project work to implement / transfer new or current product/process/material technologies for quality improvement and product enhancement, production capacity, and or cost reductions for business requirements. Develop and update specifications, test protocols and procedures. Communicate and coordinate project work with multiple functional groups within the R&D division and Manufacturing sites as the project requires. Establish communication tools with project stakeholders. Work along with R&D in the efforts of implementing new product/processes and next-generation technologies.

Task & Responsibilities:

1. Lead, perform and/or coordinate project work on process/product/system changes for quality, supply, and cost improvements, following local and division change control requirements. Support major product and process transfer to SG and MA Plant.

2. Plans, coordinates, schedules, and leads detailed phases of new and existing products transfer activities. Use Microsoft Project Gantt Charts Software as a tool to manage project status and to coordinate activities between different departments, in order to assure adherence with project scope and timing.

3. Develop, coordinate, and execute testing needed for functional qualification of parts from new/modified molds/die tooling, new/alternate materials, or new/alternative suppliers for purchased components. Where necessary, develop new or modified specifications and drawings to accommodate these alternative sources. Work with suppliers in developing mutually acceptable testing and measurement. Assure that all documentation requirements are completed per local and division change control policies.

4. Planning and coordination of validation efforts for new and existing products and/or process. Support R&D department in the development, writing and execution of IQ, OQ and PQ Protocols for the validation of product/process transfer and new or existing equipment.

5. Ensure area and personnel are in compliance with Safety requirements of the Plant. Adheres to all Environmental, Health and Safety SOP’s, Equipment, Policies and Procedure including any department specific requirements.

6. Lead, perform and/or coordinate project work on new equipment design or existing equipment changes for product/process quality, supply, and cost improvements, following local and division design control requirements. As needed for these projects develop and execute product assembly and functional testing.

7. Actively participate in the identification of continuous improvement opportunities and in the deployment of the Fenwal Production System through the FPS Academy and Kaizen activities.

8. Regulatory compliance with our environment, energy, health and safety policy.

9. Perform other duties as assigned by Supervisor.

Qualification Requirements:

· Good written and oral communication skills in Spanish and English.

· Excellent interpersonal skills and intense interest in learning.

· Ability to develop coordinates, perform and summarize the results of tests, providing fundamental information for management decisions.

· Must work with computer and software systems such as Microsoft Word, Excel, Power Point, Project, Visio, PRMS, AutoCAD, Minitab, Sample Size Determination and others, as required.

Basic understanding and application of Project Management practices according to PMI.

Education Required:

B.S. in Industrial, Mechanical, Chemical or Electrical Engineering.

Experience:

From three (3) to five (5) years of relevant professional or technical engineering experience with medical product manufacturing and/or plastics processing.

Job Types: Full-time, Permanent

Salary: $40,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Tuition reimbursement
• Vision insurance

Experience level:

• 3 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• On call
• Weekend availability

Ability to commute/relocate:

• San Germán, PR 00683: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

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