• Manufacturing Engineer II

    Astrix Technology (St. Paul, MN)


    Manufacturing Engineer II

     

    Engineering

     

    St. Paul, MN, US

     

    + Added - 16/06/2025

     

    Apply for Job

     

    Our client, a contract medical manufacturer that offers custom development and manufacturing solutions, is looking for a Manufacturing Engineer II to join their team! Partnering with various healthcare innovators our role is to transform visions into market-ready products. If you are looking to join a company that is committed to excellence and innovation in the medical device manufacturing field reach out to us today!

     

    **Type of job:** Direct Hire

    **Salary:** $75k-$110k

    Responsibilities:

    + Troubleshoot manufacturing issues using Lean Six Sigma/DMAIC and root cause analysis tools (e.g., ICARS, SCARS, CARS).

    + Support and improve existing manufacturing processes to enhance quality, efficiency, and cost-effectiveness.

    + Lead technical transfer of development jobs to production, ensuring equipment, tooling, and processes are validated and documented.

    + Write and execute IQ/OQ/PQ validation protocols; assist in compiling corresponding reports.

    + Assess, test, and qualify material changes

    + Support Lean Six Sigma initiatives

    + Identify, prioritize, and implement cost-saving opportunities that positively impact company profits.

    + Ensure compliance with Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), CFR 820, and ISO 13485 standards.

    Requirements:

    + College graduate with BSME from an accredited university and

    + Minimum of 3 years experience in a medical manufacturing environment

    + Experience with Rotary equipment, project management, root cause analysis, handling non-conformances, OGP programming, GD&T, and print reading.

    + Experience with regulatory requirements like ISO, GMP, CAPA and others.

    + Experience with IQ/OQ/PQ validation activities for medical products.

     

    _This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!_

    \#INDBH

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.