Senior System Test Engineer

Boston Scientific • Maple Grove, MN

1d

About The Position

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.

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

• Lead development and coordinate the execution of Design Validation and Verification activities for large new product development projects.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees