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

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.

Some responsibilities include:
• 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 (Intern 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

PREFERRED:
• 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 language

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