Title:  Jr System Engineer

Job Summary

In this hybrid role, the Associate Systems Engineer will work collaboratively as part of the product development team to bring new products to market and sustain existing on-market products. In this role, you will support the systems engineering team on internal or customer development programs.

Essential Duties and Responsibilities

• Demonstrates a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Characterize system and/or sub-system inputs, outputs and functionality, utilize analytical skills and develop simulation tools to define appropriate product specifications, and system reliability.
• Conduct root cause investigations and trend analysis
• Generate test setup, working with various equipment (hands-on) 
• Develop theoretical models and analysis scripts (utilizing Matlab, AI tools, etc.)
• Responsible for authoring test plans, protocols and reports required for Engineering Verification to ensure that the necessary tests are available to challenge technical requirements in the Product Requirements Matrix (PRM).
• Ensures that systems documents generated are in compliance with the global WEST Quality Management System (QMS).
• Performs data analysis and assures the appropriate data analysis techniques, analysis results, and graphical outputs are used and included in reports throughout the development process.
• Plans, coordinates, and oversees execution of testing with external vendors and test labs.
• Creates presentations and presents technical data to the team to drive project decisions and attain approvals.
• Use sound engineering principles and critical thinking skills to make risk-based decisions and drive the completion of deliverables.
• Works with the lead Systems Engineers and Project Managers to assure completion of on-time deliverables and adherence to the development schedules.
• Performs other duties as assigned based on business needs.

Education

• Bachelor's Degree In engineering discipline (or equivalent experience) required

Work Experience

• 0-3 years of experience required and
• Experience with various types of medical device design testing in accordance with FDA regulations: device functional performance, biocompatibility, sterilization, packaging, transportation simulation, real-time and accelerated aging, etc. preferred and
• Background in Reasearch and Development/product development with experience in electromechanical medical devices preferred

Preferred Knowledge, Skills and Abilities

• Excellent communication and interpersonal skills.
• Proficient in MS Office suite; including PowerPoint, Word, Excel and Outlook.
• Strong technical writing skills and experience writing test plans, protocols, and reports.
• Excellent problem-solving skills as well as keen analytical abilities.
• Knowledge of statistics and use of Minitab (a plus)
• Knowledge in software code and script development in Matlab, Python or other tool (a plus)
• Knowledge of Quality Management Systems for Medical Devices (ISO 13485), Design Controls (21 CFR 820.30), Risk Management (ISO 14971), Engineering Principles, Test Method Development, Test Method Validation (Gage RandR), and Design Verification / Validation (a plus).
• Knowledge of ISO 11608: Needle-based injection systems for medical use (a plus)
• Knowledge of IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (a plus)

License and Certifications

• Manufacturing\Six Sigma Green Belt Certification Upon Hire preferred or
• Health Services\CSSBB - Six Sigma Black Belt Upon Hire preferred

Travel Requirements

Physical Requirements