What are the responsibilities and job description for the System Verification Engineer position at KONNECTINGTREE INC?
Position: System Verification 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.