Experience Required

4 to 8 years

Location

Pune

Business Area

Ventilation (Class 2 Medical Devices)

About the Role The Systems Engineer (Product V&V;) will be part of the Engineering group, which is responsible for implementing technical strategies, evaluating and developing products, and providing a superior level of technical support that advantages the organization.

In this role, you will lead the V&V; effort with a Product V&V; focus, working closely with Engineers, Architects, and Test teams in the Ventilation business to develop and commercialize Class 2 medical devices.

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.

Key Responsibilities

Verification & Validation

- Support product verification and validation planning, resolution of technical integration issues, safety agency interface, system testing, and coordination with the customer design center
- Provide engineering expertise in software and system verification; establish system V&V; plans, assist in developing protocols, and review reports
- Implement design for testability by collaborating with R&D; teams to evaluate requirements for testability

Compliance & Certification

- Collaborate with external agencies for compliance and safety certification
- Incorporate essential operating mechanisms of systems engineering for medical device design and engineering principles
- Adhere to medical device regulations

Requirements, Architecture & Design

- Define system requirements, architecture, and interfaces to meet product requirements, risk analysis,



and industry standards
- Conduct system design analysis to select key components and define control methods
- Coordinate build and design integration

Design Reviews

- Conduct design reviews throughout product development to ensure customer requirements are met and designs are manufacturable, serviceable, and reliable
- Apply the same rigor to subsystem requirements and product integration

Required Skills & Experience

- Education: MS or PhD in a relevant field, including Computer, Electrical, or Mechanical Engineering, or a related science
- Experience: 4 to 8 years developing complex medical devices (hardware, software, consumables) for acute care/hospital markets
- Statistics: Knowledge of statistical data analysis, including the ability to critically evaluate proposed study designs, with basic knowledge of statistics, sample size calculation, and/or estimation of statistical power
- Feasibility & Trade-off Studies: Experience conducting cross-discipline studies to evaluate electronic, mechanical, and pneumatic performance from subsystem to system level for issue resolution
- V&V; Expertise: Solid understanding of system V&V; test plans/protocols, executing V&V; activities, and generating and analyzing test reports
- Regulatory: Understanding of global medical device regulatory environments and clearance processes
- Design History File (DHF): Experience auditing a DHF (a compilation of records describing the design history of a finished device) for compliance with internal processes and external standards
- Communication: Effective communication, documentation, presentation, and interpersonal skills, with the ability to work independently and as part of a team
- Confidentiality: Maintains strict confidentiality of sensitive information

📌 Systems Verification & Validation Engineer – Medical Devices (India)
🏢 Cyient
📍 India