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Manufacturing Engineer

Job in Maplewood, Ramsey County, Minnesota, USA
Listing for: VitalDyne, Inc.
Full Time position
Listed on 2025-04-23
Job specializations:
  • Manufacturing / Production
    Manufacturing Engineer, Quality Engineering
Salary/Wage Range or Industry Benchmark: 65934 - 83154 USD Yearly USD 65934.00 83154.00 YEAR
Job Description & How to Apply Below
Position: Manufacturing Engineer I

Join Vital Path in Maplewood as a Manufacturing Engineer I!

About Vital Path
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 other's success, support one another through change, and continue to grow as a high-performing organization. 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 I will be responsible for the support and troubleshooting of manufacturing floor processes and assembly with direct participation in managing CIs, quality issues investigations, and NMRs in order to ensure full compliance with 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 Maplewood, MN location. This position may require minimal travel to other Vital Path locations.

• 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 to deliver products that meet 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 to reduce costs and improve yields in the production area.
  • Provide technical support for NMRs and customer complaint investigations, performing root cause analysis, data retrieval, and tests needed and required by customers or other project-related issues.
  • Participate 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 the 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

    • 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.

    Preferred Qualifications

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

    • A working knowledge of catheter assembly manufacturing processes.

    Compensation Package

    • The salary range for this position is $65,934 - $83,154. The posted salary range complies with federal and local regulations and may vary based on factors such as market conditions, level of experience, training, education, certifications, as well as internal and external equity.

    • This position is eligible to earn an annual performance bonus based on meeting Vital Path’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, and more)

    • Parental Leave

    Paid Time Off

    • Minnesota Earned Sick & Safe Time

    • Paid Holidays

    • 401K with company match

    Opportunities for career growth and advancement

    Vital Path 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. Vital Path participates in E-Verify.

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