Senior Systems Engineer

You will deliver V-Model systems-engineering outputs, participate in design reviews, and develop and test electro-mechanical systems. You will create test methods and plans, analyze sensor data using Python, perform verification and validation, manage defects, and author technical reports.

Responsibilities

• Deliver V-Model systems engineering outputs and participate in design reviews
• Conduct development and testing against design specifications and system interactions
• Ensure assays operate efficiently and effectively
• Execute requirements, risk, configuration, defect, and verification and validation deliverables
• Develop test methods and test beds
• Perform Design of Experiments and analyze sensor data using Python
• Develop comprehensive testing plans and execute hands-on testing protocols
• Author detailed technical reports
• Manage the defect lifecycle, including collection, documentation, and summarization

Requirements

• Experience with systems engineering
• Experience with electro-mechanical devices
• Experience with Test Method Validation
• Experience with Design of Experiments
• Experience with sensor data analysis and Python
• Experience with verification and validation
• Ability to translate regulations and stakeholder mandates into testable engineering requirements
• Ability to establish bi-directional traceability using tools such as RETINA, DOORS, or Jira
• Bachelor's degree in Engineering; Electrical, Chemical, Biomedical, or Software Engineering preferred
• 8 years of experience
• FDA or FAA regulated-environment experience is a strong plus
• Medical device industry experience is ideal