Manufacturing Engineer I

About the position

The Manufacturing Engineer I will be responsible for the support and troubleshooting of manufacturing floor, processes and assembly with direct participation in managing CIs, quality issues investigations NMRs in order to ensure full compliance to FDA QSR (21 CFR 820), and applicable ISO 13485 requirements. Perform work in adherence to the VitalPath Quality Management System (QMS), including development and maintenance of documentation.

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 cross-functional 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 complaints 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.

Requirements

• High School Diploma or GED
• 1 to 3 years in a medical device manufacturing environment, with exposure to product design and Fixture design.
• 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.

Nice-to-haves

• Bachelor's degree in Plastics, Chemical, Biomedical or Mechanical Engineering
• A working Knowledge of catheter assembly manufacturing processes.

Benefits

• Comprehensive, Low Cost Health and Dental Insurance Plans Available
• Vision Insurance
• Health Savings Account with company contribution
• Short and Long Term Disability
• Supplemental insurances (short term disability, AD&D, life insurance, and more)
• Parental Leave
• Paid Time Off
• Minnesota Earned Sick & Safe Time
• Paid Holidays
• 401K with company match
• Opportunities for career growth and advancement