CathX Mfg Technician

Zeus • Arden Hills, MN

59d

About The Position

The Manufacturing Technicians are responsible for supporting process validation, process optimization, and training as defined by the quality system. Manufacturing Technician teams will develop processes and continue to analyze process capability until the process has been proven to be stable and reliable. After design and process stability has been verified, Manufacturing Technicians will engage in production transfer and training activities. Once processes have been transferred, Manufacturing Technicians will continue to support engineering to sustain and optimize processes. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).

Requirements

• AA Degree or equivalent work experience in related discipline and 3 years of related experience in the medical device industry
• Working knowledge of engineering principles and ability to read and comprehend work instructions, schematics and design documentation
• Experience with welding, braiding, coiling, heat shaping, hot air bonding, swaging and fusing is preferred
• Critical thinking, troubleshooting and problem-solving ability
• Ability to work independently as well as part of a team
• Proficiency with Microsoft desktop environment: Windows, Word, Excel, and Outlook
• Good written and verbal communication skills
• General Catheter Assembly
• Good Lab Notebook Skills
• Draft MPIs
• Medical device manufacturing processes
• Understanding of Good Manufacturing Processes and Good Documentation Processes
• The technician must work proficiently to deliver on or ahead of schedule.

Nice To Haves

• Proficiency with SolidWorks, and Minitab is a plus
• Basic anatomy and product use are not required but encouraged
• 5 years' experience
• Propose Process Improvement
• Solve Complex Problems

Responsibilities

• Assist the engineering team with process development and optimization including: rapidly prototyping fixtures, troubleshooting failures, proposing and evaluating design and process improvements
• Assemble Class II and III prototype components, subassemblies and assemblies
• Works from product specifications and written/verbal instructions.
• Develop and execute tests for new and improved design concepts processes, procedures, and test methods.
• Record build data in laboratory notebooks
• Develop, design and implement efficient and useful fixtures and tooling for manufacturing and process improvements of new or modified products / processes
• Review, develop, and improve manufacturing instructions
• Maintain detailed documentation through all phases of development, testing and analysis
• May assist in the transfer of technology and/or contribute in cross-functional discussions regarding device performance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree