Overview
Skills
Job Details
Job Summary: Talent Software Services is in search of a Quality Engineer for a contract position in Maple Grove, MN. The opportunity will be ten months with a strong chance for a long-term extension.
Position 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 a 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 methods and equipment development to satisfy product requirements.
Primary Duties & 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.
Qualifications:
- Bachelor's degree in biomedical engineering, Materials Engineering, Chemical Engineering or related field of study.
- Degree must be completed and clearly stated on the resume.
- 0-2 years of experience in design assurance, new product development or relatedmedical 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 Measurement 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
If this job is a match for your background, we would be honored to receive your application!
Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities, including contract, contract to hire, and permanent placement. Let's talk!