Systems Verification & Validation Lead - Medical Devices.

Job Description : Systems V&V Engineer (Product Verification & Validation Lead) Medical Devices.

Experience required : 8 to 12 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 8 to 12 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.