System Verification Engineer

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Position: System Validation Engineer

Location: Minneapolis, MN

Type: Contract

Job Description

Years of experience required: 3 - 7 years

Job Summary:

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)
• 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
• 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.
• Provides technical leadership on a cross-functional engineering team.
• 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 EMC according to 60601-1
  
  

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.
  
  

Education:

Master’s / Bachelor’s degree in Computer Engineering, Computer Science, or equivalent.