Development Sr Engineer

Artech LLC

  • Warsaw, IN
  • 27 days ago

    Highlights

    Bachelor’s degree in Engineering ; Mechanical, Biomedical, Bioengineering, Materials, Chemical, Polymer or related preferred. 3+ years relevant engineering experience ; 3–5 years medical device product development strongly preferred.

    Numbers & Facts

    LocationWarsaw, IN

    Description

    Job Title: Development Sr Engineer
    Location: Warsaw, IN 46580 – Hybrid (3 days onsite)
    Duration: 12 Months
    Travel: Up to 25%

    Must-Have Requirements

    • Bachelor’s degree in Engineering; Mechanical, Biomedical, Bioengineering, Materials, Chemical, Polymer or related preferred.
    • 3+ years relevant engineering experience; 3–5 years medical device product development strongly preferred.
    • Hands-on experience with Design Controls, Risk Management, and regulated medical devices.
    • Knowledge of 21 CFR Part 820/QSR, ISO 13485, and ISO 14971.
    • Experience with NPD, feasibility, design changes, technology integration, or manufacturing/product transfer.
    • Strong technical writing, documentation, communication, and cross-functional project coordination.
    • Engineering statistics: sample size, DOE, hypothesis testing.
    • Microsoft Office proficiency.
    • Able to work 3 days onsite in Warsaw, IN and travel up to 25%.

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