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Systems Test Engineer I- Medical Device (Onsite - Maple Grove, MN) Possible Temp-to-Hire
Systems Test Engineer I- Medical Device (Onsite - Maple Grove, MN) Possible Temp-to-HireZipRecruiter • Osseo, MN, US
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Systems Test Engineer I- Medical Device (Onsite - Maple Grove, MN) Possible Temp-to-Hire

Systems Test Engineer I- Medical Device (Onsite - Maple Grove, MN) Possible Temp-to-Hire

ZipRecruiter • Osseo, MN, US
6 days ago
Job type
  • Full-time
Job description

Overview

Job Description Our Fortune 500 Medical Device has an exciting opportunity for a Systems Test Engineer I.

Job Summary

The Systems Test Engineer is a Design Quality Engineer that directly supports medical device product development from concept through commercialization. Employee will work with high-performance cross-functional sustaining team to ensure safety, quality and compliance of launched products while continuously improving their commercial value through end-of-life. This position will focus on test method and equipment development to satisfy product requirements.

Responsibilities

  • Actively promote and participate in a cross-functional teamwork environment.
  • Develop test equipment to satisfy product requirements for design verification from concept to functional equipment.
  • Support lab activities to create clinical phantoms for medical device evaluation.
  • Execute fabrication of design by utilizing various additive (3D Printing) manufacturing techniques.
  • Write various technical documentation for procedure execution, technical rationale and evidence of the development process.
  • Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Support the verification, validation, and usability testing to meet or exceed internal and external requirements.
  • Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
  • Understanding human anatomy and physiology and be able to apply that knowledge to the usage of medical devices.

Minimum Qualifications

  • Bachelor's degree in biomedical engineering, Materials Engineering, Chemical Engineering or related field of study.
  • Degree must be completed and clearly stated on resume.
  • 0-2 years of experience in design assurance, new product development or related medical device / regulated industry experience.
  • Lab experience from classes or research positions.
  • Self-motivated with a passion for solving problems and a bias for action.
  • Hands-on approach to product development.
  • Strong communication skills (verbal & written).
  • Demonstrated use of Quality tools / methodologies.

    • Additional Qualifications

  • ISO 13485, ISO 14971 and Quality System Regulations understanding with focus on Design Controls & Risk Analysis.
  • Previous development of testing and / or automated equipment.
  • Previous experience with Measurements System Analysis.
  • Experience integrating data acquisition equipment and clinically relevant simulated environments.
  • Experience working with Hydrogel.
  • Experience utilizing additive manufacturing.
  • Experience using SolidWorks 3D Modeling Software or equivalent.
  • Experience using Minitab statistical software.
  • Experience using Matlab programming.

    • Other Details

  • Schedule : 08 : 00 AM - 04 : 30 PM CST
  • Contract Length : 9 months (possible temp-to-hire)
  • Work Set-Up : Onsite - Maple Grove, MN
  • Start Date : 9 / 29 / 2025

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    System Test Engineer • Osseo, MN, US