Systems Test Engineer I- Medical Device (Onsite - Maple Grove, MN) Possible Temp-to-HireZipRecruiter • Osseo, MN, US
Systems Test Engineer I- Medical Device (Onsite - Maple Grove, MN) Possible Temp-to-Hire
ZipRecruiter • Osseo, MN, US
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job_description.job_card.job_descriptionBachelor'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. 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. 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
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
Additional Qualifications
Other Details
J-18808-Ljbffr
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System Test Engineer • Osseo, MN, US
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