Manufacturing Engineer

Manufacturing Engineer I

Join Vital Path in Cokato as a Manufacturing Engineer I!

Vital Path is a trusted contract manufacturing partner that delivers high-quality complex catheter solutions around the world that save lives and restore patient health and vital function. We strive to treat every product we design and manufacture to the highest level of quality and awareness that these products are going to be used inside of a patient, possibly even our own family members.

Our employees impassioned hard work and dedication are at the core of our success. Every function within our organization plays a crucial role in our mission and is deeply valued for its contribution to achieving our shared goals of quality, innovation, continuous improvement, and operational excellence.

As a fast-growing organization, we bring harmony and standardization across Vital Path with a strong vision in mind - We are one Vital Path. We embrace our diversity, celebrate each others success, support one another through change, and continue to grow as a high-performing organization. We aim to shape our corporate culture to enhance team member engagement, skills, and productivity so that Vital Path is an employer of choice.

If you're ready to contribute to groundbreaking medical advancements in a collaborative, fast paced environment, we invite you to apply and be part of our growth!

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 Vital Path Quality Management System (QMS), including development and maintenance of documentation.

Work Location/Schedule

· This position requires the employee to be onsite at our Vital Path Cokato, MN location.

· Vital Path does not offer relocation assistance for this position.

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 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

Required Qualifications

· High School Diploma or GED or equivalent experience

· 1-3 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

· 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

Preferred Qualifications

· Bachelor's degree in Plastics, Chemical, Biomedical, or Mechanical Engineering

Compensation Package

· The salary range for this position is $74,462 - $95,669. The posted salary range complies with federal and local regulations and…