Medical Engineering Consultants (MEC) ยท 4 months ago
Systems Test Engineer
Maple Grove, MN
Full-time
Onsite
New Grad, Entry Level
0+ years expMedical Engineering Consultants (MEC) support medical device and pharmaceutical companies by providing resources, knowledge, and expertise to enhance their productivity. The Systems Test Engineer will support medical device product development, focusing on test method and equipment development to ensure safety, quality, and compliance of launched products while improving their commercial value.
ConsultingMedical DevicePharmaceuticalTraining
No H1B
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 and 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
Qualification
Required
Bachelors 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
Company
Medical Engineering Consultants (MEC)
MEC is a comprehensive solution provider with a full suite of services from consulting and contracting to training and cost savings initiatives.
Founded in 2011Fort Lauderdale, Florida, USA
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Christopher Gustine
Managing Partner
David Campo
Managing Partner
Company data provided by crunchbase