Embedded Test Engineer

Job Description :Embedded Test Engineer.

Experience required : 1 to 5 years

Location : Pune.

The Systems Engineer (Product V&V (Verification and Validation)) will be a part of the Engineering group that is responsible for implementing technical strategies, evaluate and develop products, and provide a superior level of technical support that benefits the organization. The Systems Engineer will lead the V&V effort / with a Product V&V focus collaborates closely with Engineers, Architects, and Test in the Ventilation business to develop and commercialize Class 2 medical devices.  

Responsibilities:  

• Works together to support product verification and validation planning, resolution of technical integration issues, safety agency interface, system testing and coordination and interfaces with Customer design center. 
• Provides engineering expertise in software and system verification and establishes system V&V plans, assists in developments of protocols and reviews reports. 
• Implements design for testability by collaborating with R&D (Research and Development) teams to evaluate requirements for testability. Collaborates with external agencies for compliance and safety certification 
• Incorporates essential operating mechanisms of systems engineering of medical device design and engineering principles and adheres to medical device regulations. 
• Defines system requirements, architecture, and interfaces to meet product requirements, risk analysis and industry standards; conducts system design analysis to select key components and defines control methods; and coordinates build and design integration. 
• Conducts design reviews as part of the product development process to ensure customer requirements are met and the designs are manufacture-able, serviceable, and reliable. In addition, it does the same for subsystem requirements and product integration.  

Behaviors: The successful candidate will demonstrate the following: 

• Leadership: The ability to make things happen by encouraging and channeling the contributions of others; recognizing and addressing critical issues in a timely manner and acting as an agent for change and continual improvement when required to achieve results.  
• Accountability/Ownership: Work closely with team members and take ownership – be a mentor to junior engineers   
• Influence: The demonstrated ability to gain acceptance and commitment from others to one’s own beliefs and ideas. 
• Negotiating: The ability to construct and maintain a strong bargaining position to ensure positive response and agreement: striving for win-win situations. 
• Adaptability: Must possess the ability to understand new concepts quickly and apply them accurately throughout an evolving environment and organize work assignments to meet established timetables. 
• Data-driven decision-making: ability to move teams through vague and complex situations. Present complex ideas in a simple manner to resolve issues. 
• Relentless focus on Quality and Transparency as an organizational value. 

The systems team drives the systems elements of R&D development projects including systems requirement definition and management, architectural definition, control/software/interface product specification and simulation, build integration, system testing and qualification to meet product level requirements. 

To succeed in this role, you should have the following skills and experience: 

• MS or PhD in relevant field including Computer, Electrical, Mechanical Engineering, or other related science.  
• A minimum of 1 to 5 years of experience successfully developing complex medical devices (hardware, software, consumables) products for acute care/hospital markets is necessary. 
• Hands-on experience (technical) in ventilation is a plus. 
• Knowledge of Statistical Data Analysis is necessary. Includes ability to critically evaluate proposed study designs with basic knowledge of statistics, the calculation of sample sizes and/or estimation of statistical power. 
• Experience with conducting cross-discipline feasibility and trade off studies to evaluate electronic, mechanical, and pneumatic performance from subsystem to system level for issue resolutions  
• Solid understanding of System Verification and Validation test plan/protocols, executing V&V activities, generating, and analyzing test reports 
• Understanding of global medical device regulatory environments and clearance processes. 
• Effective communication, documentation, presentation, and interpersonal skills are required, as well as the ability to work both independently and as part of a team. 
• Experience auditing a DHF (Design History File - a compilation of records which describe the design history of a finished device) for compliance with internal processes and external standards. 
• Maintains strict confidentiality of sensitive information. 

Skills Required

IEC 60601, ISO 13485 Audit, Product Verification, System Verification, System Designs, V-Model, Testing Techniques, Test Method Validation, ISO 14971 Risk Management

Role

Job Description :Embedded Test Engineer. Experience required : 1 to 5 years Location : Pune. The Systems Engineer (Product V&V (Verification and Validation)) will be a part of the Engineering group that is responsible for implementing technical strategies, evaluate and develop products, and provide a superior level of technical support that benefits the organization. The Systems Engineer will lead the V&V effort / with a Product V&V focus collaborates closely with Engineers, Architects, and Test in the Ventilation business to develop and commercialize Class 2 medical devices.   Responsibilities:   Works together to support product verification and validation planning, resolution of technical integration issues, safety agency interface, system testing and coordination and interfaces with Customer design center.  Provides engineering expertise in software and system verification and establishes system V&V plans, assists in developments of protocols and reviews reports.  Implements design for testability by collaborating with R&D (Research and Development) teams to evaluate requirements for testability. Collaborates with external agencies for compliance and safety certification  Incorporates essential operating mechanisms of systems engineering of medical device design and engineering principles and adheres to medical device regulations.  Defines system requirements, architecture, and interfaces to meet product requirements, risk analysis and industry standards; conducts system design analysis to select key components and defines control methods; and coordinates build and design integration.  Conducts design reviews as part of the product development process to ensure customer requirements are met and the designs are manufacture-able, serviceable, and reliable. In addition, it does the same for subsystem requirements and product integration.   Behaviors: The successful candidate will demonstrate the following:  Leadership: The ability to make things happen by encouraging and channeling the contributions of others; recognizing and addressing critical issues in a timely manner and acting as an agent for change and continual improvement when required to achieve results.   Accountability/Ownership: Work closely with team members and take ownership – be a mentor to junior engineers    Influence: The demonstrated ability to gain acceptance and commitment from others to one’s own beliefs and ideas.  Negotiating: The ability to construct and maintain a strong bargaining position to ensure positive response and agreement: striving for win-win situations.  Adaptability: Must possess the ability to understand new concepts quickly and apply them accurately throughout an evolving environment and organize work assignments to meet established timetables.  Data-driven decision-making: ability to move teams through vague and complex situations. Present complex ideas in a simple manner to resolve issues.  Relentless focus on Quality and Transparency as an organizational value.  The systems team drives the systems elements of R&D development projects including systems requirement definition and management, architectural definition, control/software/interface product specification and simulation, build integration, system testing and qualification to meet product level requirements.  To succeed in this role, you should have the following skills and experience:  MS or PhD in relevant field including Computer, Electrical, Mechanical Engineering, or other related science.   A minimum of 1 to 5 years of experience successfully developing complex medical devices (hardware, software, consumables) products for acute care/hospital markets is necessary.  Hands-on experience (technical) in ventilation is a plus.  Knowledge of Statistical Data Analysis is necessary. Includes ability to critically evaluate proposed study designs with basic knowledge of statistics, the calculation of sample sizes and/or estimation of statistical power.  Experience with conducting cross-discipline feasibility and trade off studies to evaluate electronic, mechanical, and pneumatic performance from subsystem to system level for issue resolutions   Solid understanding of System Verification and Validation test plan/protocols, executing V&V activities, generating, and analyzing test reports  Understanding of global medical device regulatory environments and clearance processes.  Effective communication, documentation, presentation, and interpersonal skills are required, as well as the ability to work both independently and as part of a team.  Experience auditing a DHF (Design History File - a compilation of records which describe the design history of a finished device) for compliance with internal processes and external standards.  Maintains strict confidentiality of sensitive information.

Desirable Skills

IEC 60601, ISO 13485 Audit, Product Verification, System Verification, System Designs, V-Model, Testing Techniques, Test Method Validation, ISO 14971 Risk Management

Designation

Associate