Product Verification & Validation Lead

The 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 Philips 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.
• Relentlessfocus on Quality and Transparencyas 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.

Skills Required

Building Architecture,Design Integration,System Verification,Medical Devices,Leadership,Medical Devices Design,Validation Plans,Verification and Validation (V&V),Process Development (PD),System Designs,Product Specifications,Results-Oriented,Product Development,FDA Medical Device Regulations,Design,Design Analysis,Medical Device Regulations,System Requirements,Research and Development Operations,Identifying Customer Needs,People Management,Product Requirements,Development Projects

Location

Pune, India

Desirable Skills

Building Architecture,Design Integration,System Verification,Medical Devices,Leadership,Medical Devices Design,Validation Plans,Verification and Validation (V&V),Process Development (PD),System Designs,Product Specifications,Results-Oriented,Product Development,FDA Medical Device Regulations,Design,Design Analysis,Medical Device Regulations,System Requirements,Research and Development Operations,Identifying Customer Needs,People Management,Product Requirements,Development Projects

Designation

Associate