System Test Engineer

Role name:
System Test Engineer

Work Location:

Minneapolis, MN – working from Client office (Onsite)

Role and responsibilities:

This position requires Engineer with a strong background in system verification and a deep understanding of the product development life cycle especially in electro-mechanical medical device. The ideal candidate will help us and our clients by designing, developing, and verification of Test Methods, Protocols on a Linux based platform to ensure the quality and reliability of our software applications.
Skills & Knowledge Requirements
Must have Knowledge of QMS, SoPs along with working in regulated industry for system verification is mandatory.
Must have hands-on experience of working in remediation programs (e.g. gap analysis, DHF remediation, design remediation, compliance remediation).

Experience of working in medical device is mandatory – at least 2 full cycle system verification of products (e.g. 3-4 years of working experience in medical device out of total 6 – 7 years of working experience)
Provides technical leadership on a cross-functional engineering team.
Defines and analyzes system requirements, clinical workflows, and input/output processes by using current systems engineering methods and technologies.

Experience of system verification (working in Lab) of electro-mechanical products, mixed Hardware & software systems – at least one full cycle starting from understanding of product requirement till system verification
Hands on experience in test method validation, especially analysis based on intended usage collecting objective evidence on consistent basis.
Knowledge of risk management of product – failure mode analysis and articulating system verification test cases and expertise in writing verification protocols
Documents system architecture and design control elements by writing documents, reports, and memos.
Translates customer needs into technical requirements, engaging the field, marketing, service and other functions as needed.
Leads and assists with industry-based standards testing for safety and EClient according to 60601-1
Works with a cross-functional team and serves as an R&D representative on cross-functional deliverables. Creating test set-up including experience in handling of test fixture especially on trouble shooting, making it work, collecting consistent data.
Execution of tests, including user level experience in working with Linux workstation
Report writing, discussion with various stakeholders including product requirements, QA & RA teams
Knowledge in OOO programming languages such as Python, JAVA, C++ is an added advantage.
Good to have:
Strong knowledge of laboratory equipment such as DSO (Digital Storage Oscilloscope), multimeter, and logic analyzer, along with familiarity with analog and digital electronics (e.g., DC-DC converters, sensor interfaces, microcontrollers)
Hands-on experience with MATLAB, with working knowledge of Python as an added advantage
Proficiency in Linux operating systems and familiarity with Agile methodologies and development practices
Job Responsibility
Develop Verification Plans:
Create comprehensive verification plans that outline the testing strategy for system-level functionality, ensuring alignment with product requirements and specifications.
Conduct Testing:
Perform various types of testing, including functional, performance, and stress testing, to validate the system's performance and reliability under different conditions.
Create and Execute Test Cases:
Design and execute test cases based on requirements and design documentation, ensuring thorough coverage of all functionalities.
Identify and Report Issues:
Detect, track, and resolve bugs and issues that arise during testing. This includes documenting findings and collaborating with development teams to enhance product quality.
Collaborate with Development Teams:
Work closely with software and hardware development teams to provide feedback and insights that can improve the overall product quality and performance.
Analyze Requirements:
Understand and analyze product requirements and specifications to ensure that the verification process is aligned with the intended functionality.