Job description

About VitalPath: VitalPath is a trusted partner in the catheter design and manufacturing of custom medical devices that save lives and restore patient health and vital function. We’re excited about this important work and bring vital energy to our customer partnerships. In our growing organization it’s important that we continue to offer a small-company, family-oriented environment with competitive pay and benefits. If you want to make a difference in people’s lives and be a part of a friendly, fun place to work with people that value diversity, come join our team!

About the position:

The Manufacturing Engineer 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 CMD Quality Management System (QMS), including development and maintenance of documentation.

Job Duties

• 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 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.

Requirements

• 1 to 3 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.
• High School Diploma or GED required
• Bachelor's degree in Plastics, Chemical, Biomedical or Mechanical Engineering preferred
• Understanding of Lean principles and basic Lean Tools
• Experience with design controls, FDA regulation, GMP practices, and QSR requirements

Benefits of working at VitalPath:

• 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)
• Paid Time Off
• Paid Holidays
• 401K with company match
• Competitive compensation
• Opportunities for career growth and advancement

Job Type: Full-time

Pay: $1.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 1 year
• 2 years
• 3 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person
• Manufacturing facility

Ability to commute/relocate:

• Saint Paul, MN 55113: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

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