System Test Engineer

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 , with working knowledge of Python as an added advantage 
Proficiency in Linux operating systems and familiarity with Agile methodologies and development practices