Location: Maple Grove, MN (75% onsite) *LOCAL CANDIDATES ONLY*

8+ months, Contract to Hire

Compensation: $45 - $51/hour




POSITION SUMMARY:

The Manufacturing Engineer is a key role in the execution of Global Labeling Solution (GLS) strategic project. The GLS system provides a single global software solution for design, change management and printing of labels.



The Manufacturing Engineer primary function is to implement the GLS system within Maple Grove production. Key deliverables include process validation for printers with new labelling software, operator training and Pilot of system within the site production lines. These product lines include coronary and peripheral interventional products such as guide extension catheters, microcatheters, snares catheters, guidewires, and hemostasis valves.



PRINCIPAL RESPONSIBILITIES:

• Lead Pilot of GLS system within production. This activity includes testing integration of the software with ERP system to ensure lot specific data is printed accurately on labels.
• Perform process qualification and validation activity. This activity includes completion of Validation Plan, Installation Qualification (IQ), Performance Qualification (PQ) of Zebra and Epson printers with label print software including creation of protocols and final report.
• Execution of validation requirements for implementation of label print software for printing product labeling across all product lines in operations.
• Coordinate with label design group the labels required to execute Validation Plan and Pilot within production.
• Support investigations tied to any incidents raised with implementation of system. Produce as team member of investigative team as required for leadership or engineering technical assistance.
• Perform label test printing and support other labeling implementation activities as required, coordinate with label design team and local operations personnel as required.
• Support training of operations personnel on system in accordance with global process work instructions.
• Update local work instructions as required to transition to future state label print process.
• Demonstrate basic project management skills including but not limited to defining scope, identifying measurable results, methods and resources necessary for improvement, timeline management and capable results.

Must haves:

• Exceptional hands-on engineering skills and ability to work on production equipment.
• Experience with Process validation execution and technical writing skills to create protocols and reports.
• Capable of executing projects with operational results with minimal guidance.
• Excellent communication and coordination skills.

EDUCATION / EXPERIENCE REQUIREMENTS:

• 4 year degree in an Engineering discipline - Mechanical, Biomedical, Plastics, Industrial, etc.
• Minimum 3 years as Manufacturing Engineer/equivalent with regulated environment experience (medical device experience preferred).