Embedded Test Engineer

Cyient; Maharashtra; Sur place; INR 600 000 - 1 000 000; Plein temps

Résumé du poste

Cyient in Pune is seeking an Embedded Test Engineer to lead V&V activities for Class 2 medical devices. The role focuses on verification and validation planning, system testing, and ensuring compliance with safety and regulatory requirements.

You will collaborate with R&D, design, and test teams to develop robust testability and drive quality. Experience: 1–5 years in medical device development, knowledge of statistical data analysis, and strong communication.

Qualifications

• MS/PhD in a relevant engineering field.
• 1–5 years of experience in developing medical devices (hardware/software).
• Knowledge of system V&V and regulatory environments.

Responsabilités

• Supports product verification and validation planning and test execution.
• Provides engineering expertise in software and system verification; develops V&V plans and review reports.
• Collaborates with R&D, design, and test teams to ensure testability and compliance for medical devices.
• Conducts design reviews and ensures products meet customer requirements, manufacturability, serviceability and reliability.
• Maintains confidentiality and adheres to regulatory requirements.

Connaissances

V&V planning

System testing

Verifications & validations

Cross-functional collaboration

Data analysis

Communication

Leadership

Formation

MS or PhD in Computer/Electrical/Mechanical Engineering

Description du poste

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.