• Senior Process Development Engineer - Catheter

    LCI-Lawinger Consulting (Fridley, MN)


    Job Type: Contract or Direct Hire

    Job Summary

    The Senior Process Development Engineer supports the development, optimization, and validation of manufacturing processes for complex catheter-based delivery systems. The role focuses on post–design-freeze activities such as tooling, fixtures, process characterization, and validation (IQ/OQ/PQ). This engineer serves as a subject-matter expert on cross-functional teams and drives scalable, high-quality production processes.

    Key Responsibilities

    + Develop and validate manufacturing processes for catheter-based delivery systems (e.g., reinforced shafts, balloons, steerable components).

    + Lead process optimization activities, including DOE studies and data analysis.

    + Create tooling, fixtures, and equipment strategies to improve process efficiency and operator usability.

    + Support smooth transfer of designs into stable, validated production processes.

    + Prepare process development plans, documentation, and validation protocols (IQ/OQ/PQ).

    + Drive improvements in production controls, safety, training, and quality systems.

    + Support cross-functional activities including operations, quality, program management, and documentation updates (ECOs).

    + Participate in manufacturing readiness and gate reviews.

    Qualifications

    + Bachelor’s degree in engineering or related field.

    + 5+ years of experience in process or product development.

    + Hands-on experience with catheters, balloons, shafts, or similar component manufacturing.

    + Strong understanding of DFM, design controls, statistical analysis, and validation methods.

    + Proficiency in SolidWorks or similar tools and general MS Office programs.

    + Ability to manage multiple projects and collaborate across teams.

    Physical Requirements

    + Ability to work at a computer for extended periods.

    + Ability to lift up to 25 lbs when needed.

    + Good hand–eye coordination and visual differentiation of small components.

    + Ability to wear appropriate cleanroom attire when required.

     

    Pay: $100k-$135k DOE Direct Hire

     

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