Senior System Test Engineer

Boston Scientific•Maple Grove, MN

21h•$82,600 - $156,900•Onsite

About The Position

Senior System 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 mechanical design and test equipment development to satisfy product requirements.

Requirements

Bachelor’s degree in Biomedical Engineering, Mechanical Engineering or related field of study
5+ years of experience in design assurance, new product development or related medical device / regulated industry experience
Self-motivated with a passion for solving problems and a bias for action
Hands-on approach to product development
Experience using Solidworks 3D Modeling Software or equivalent
Strong communication skills (verbal & written)
Demonstrated use of Quality tools/methodologies
ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
Travel as required (10%)

Nice To Haves

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 using Minitab statistical software
Experience using MATLAB programming language

Responsibilities

Actively promote and participate in a cross-functional teamwork environment.
Lead development and coordinate the execution of Design Validation and Verification activities for large new product development projects.
Independently make decisions and work with limited supervision. Take ownership of tasks and projects, without direct oversight.
Develop test equipment to satisfy product requirements for design verification from concept to functional equipment.
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.
Guide cross functional team through product development process; specifically, with respect to design control and risk management deliverables.