Manufacturing Engineer I

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

Join VitalPath in Cokato as a Manufacturing Engineer I!

VitalPath 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 VitalPath with a strong vision in mind - We are one VitalPath. 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 VitalPath 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 VitalPath Quality Management System (QMS), including development and maintenance of documentation.

Work Location/Schedule

• This position requires the employee to be onsite at our VitalPath Cokato, MN location.
• VitalPath 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 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.

Required 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.

Preferred Qualifications

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

Compensation Package

• The salary range for this position is $74,462 to $95,669. The posted salary range complies with federal and local regulations and may vary based on factors such as market conditions, level of experience and training, education, certifications, as well as internal and external equity.
• This position is eligible to earn an annual performance bonus based on meeting VitalPath’s bonus performance plan.

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, MN paid family & medical leave, and more).
• Parental Leave.
• Paid Time Off.
• Minnesota Earned Sick & Safe Time.
• Paid Holidays.
• 401K with company match.
• Opportunities for career growth and advancement.

VitalPath is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, work related mental or physical disability, veteran status, sexual orientation, gender identity, or genetic information. VitalPath participates in E-Verify.