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Job Summary
The Project Engineer is responsible for managing assigned customer projects once the PO is received through process development, validation, and production. Responsible for creating a schedule and managing/achieving scope, deadlines, commitments, follow up, risks, problems, solutions, change requests, and timely and clear communication between customer and cross-functional internal team members. Presenting and upholding the values and integrity of ISO13485 continuous improvement at Isometric Micro Molding, Inc.

Essential Functions and Responsibilities:

• Responds to customer within 24 hours and provides proactive customer follow-up.
• Provides timely and clear communication to customers and cross-functional internal team members.
• Creates project timelines and successfully achieves and meets deadlines and commitments.
• Serve as customer point-of-contact for assigned projects.
• Implement solutions that meet customer expectations.
• Lead assigned injection molding projects through process development, validation, and production.
• In collaboration with the Development Engineering group, establish redlines from customer supplied data for assigned project mold design & builds.
• Collaborate with Development and Automation teams to determine best manufacturing approaches for projects requiring automation.
• Ensure all changes in project scopes are managed and costs controlled.
• Identify and monitor overall program costs, timing, and deliverables to ensure key milestones are achieved.
• Collaborate with cross-functional team members to schedule resources required for timely execution.
• Oversee assigned project validations through protocol development, installation qualification (IQ), initial testing, troubleshooting, process development, operational qualification (OQ), and production qualification (PQ).
• Develop DOE’s, FMEA’s, Production Documentation, and Control Plans.
• Work with Quality to establish inspection methods for assigned projects.
• Comply to the requirements of ISO 9001, ISO 13485, and ITAR as required.
• Ongoing support of production throughout entire life cycle of product.
• Knowledge of Quality and Continuous Improvement.
• Manage and perform ECO process on assigned projects.
• Establish preventive maintenance procedures to safeguard equipment and the quality of manufactured product.
• Trouble-shoot and solve production manufacturing issues for assigned projects.
• Work with sales team to determine pricing and delivery for project deliverables.
• Travel to Customer facilities as required.

Day Shift 8 hours

Isometric is an Equal Opportunity Employer

We Offer Competitive Benefits and Wages

Job Type: Full-time

Education and/or Experience:

• Bachelor’s degree in Engineering with the following directly related experience:
• Minimum (5) years applied engineering experience
• Minimum (5) years of demonstrated project management experience
• Minimum (5) years of demonstrated validation experience
• Broad knowledge of resin and other materials
• Broad knowledge of precision manufacturing
• Experience in injection molding
• Experience in injection mold tooling
• Experience with 3D CAD software and understanding of how injection mold tooling is designed
• Experience with reading and understanding part drawings
• Demonstrated knowledge of interpreting metrology and physical testing data
• Medical device and/or Pharma industry experience highly preferred
• Understanding of ISO13485 and its requirements
• Understanding and analysis of Design of Experiments (DOE)