Manufacturing Engineer I – Catheter Manufacturing

VitalPath; Cokato (MN); On-site; USD 74,462 - 95,669; Full time

Benefits offered by this job

Health insurance

Dental insurance

401(k) with company match

Paid time off

Job summary

VitalPath in Cokato, MN is seeking a Manufacturing Engineer I to support and troubleshoot manufacturing floor processes and assembly, ensuring compliance with FDA QSR (21 CFR 820) and ISO 13485. You’ll develop documentation within the QMS and take part in continuous improvement initiatives.

You will collaborate with RD and Quality to deliver products that meet customer requirements, update BOMs and work instructions, and train technicians.

Qualifications

• High School Diploma or GED or equivalent experience.
• 13 years in a catheter manufacturing environment, with exposure to product design and fixture design.
• A working knowledge of catheter assembly manufacturing processes.
• Demonstrated excellent written and oral communication skills.
• Understanding of Lean principles and basic Lean Tools.
• Experience with design controls, FDA regulation, GMP practices, and QSR requirements.
• Able to sit and/or stand for extended periods of time.
• Able to lift up to 25 pounds.

Responsibilities

• Support the troubleshooting of equipment and manufacturing processes.
• Develop bills of materials and assembly methods, update work instructions and provide any needed training to technicians and assemblers related to processes and equipment.
• Work in a crossfunctional environment partnering with RD and Quality departments in order to deliver product that meets customer requirements, on time delivery and quoted price.
• Create tooling and fixtures to improve the manufacturing processes and ease the operators job in the assembly area.
• Support and execute CI projects in order to reduce the cost and improve yields in the production area.
• Working knowledge of manufacturing processes related to catheter manufacturing.
• Provide technical support for NMRs and customer complains investigations, performing root cause analysis, data retrieval and tests needed and required by customers or other project related issues.
• Participates in the execution of protocols for Qualifications, Validations, Verification and Validation testing, and Process FMEAs.
• Actively participate in all Lean manufacturing events and initiatives taking place on manufacturing floor.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Other duties as assigned.

Skills

Communication

Lean principles

Design controls

QSR/GMP

Catheter manufacturing

Cross-functional collaboration

Education

Bachelor’s degree in Plastics, Chemical, Biomedical, or Mechanical Engineering

Job description

VitalPath in Cokato, MN is seeking a Manufacturing Engineer I to support and troubleshoot manufacturing floor processes and assembly, ensuring compliance with FDA QSR (21 CFR 820) and ISO 13485. You’ll develop documentation within the QMS and take part in continuous improvement initiatives.

You will collaborate with RD and Quality to deliver products that meet customer requirements, update BOMs and work instructions, and train technicians.