System test Engineer

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 EMC 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.

The pay range that the employer in good faith reasonably expects to pay for this position is $23.11/hour - $36.12/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis.

Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.

Salary : $23 - $36