Job Description

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You\'ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter\'s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives\xe2\x80\x94where your purpose accelerates our mission.

Job Title: Mgr, System V & V

Summary:

Lead technical team members in the application of standard system engineering principles, methods, and techniques to resolve difficult problems focused on verification & validation. Develop strategy for the Verification and Validation and execute as per plan. Lead project assignments in the evaluation, selection and adaptation of various techniques, procedures, and criteria with minimal guidance. Based on significant process and technical expertise, review and approve verification plans and methods and provides general direction to verification engineering staff. Report out on the progress to senior management.

Contribute to System Verification Engineering vision that aligns with the organization\'s vision and strategic plan. Utilize solid understanding of engineering theory and best-practice in a variety of disciplines to manage complex projects or programs within boundaries of quality, time, and budget. Provide direction to technical team members that are accountable for system verification engineering activities.

Essential Duties and Responsibilities:

• Lead the planning, development and execution of system verification and validation deliverables (test plans, test protocols, test cases, traceability matrices, test reports, studies, Installation/Operational/Performance Qualification Protocols). Engage in test planning during design and development phases.
• Participates and contributes to the roadmap discussion.
• Pair up with design & development team to start the testing early in the design cycle to ensure the requirements testability, design traceability & test coverage. Identify issues early to fix the same. Refine the test plans and procedures through pre-verification / Dry runs.
• Provide Technical direction for Systems Verification and Validation Engineering staff and programs.
• Clear understanding and proven experience on the elements of Risk Management, FMEA, critical / Essential parts identification, System reliability, Life / limits testing and related V&V tasks.
• Lead the qualification of lab area, productivity improvement efforts, including testing, building fixtures, calibration, and data collection.
• Guides the team in investigations for identifying the root cause and drives actions to prevent such issues from recurring.
• Adheres to Baxter Quality Management system & front ends the quality audits.
• Contribute to the development and documentation of system requirements, systems architecture, and design.
• Manage the integration of deliverables from subsystem teams, cross functional teams (risk management, compliance, etc.) and external partners.
• Implementing configuration and change management through the complete product life-cycle, including verification and validation deliverables.
• Actively communicate and advocate team\xe2\x80\x99s capabilities and accomplishments.
• Create opportunity to automate testing and optimize test processes. Leverage and enhance existing automation framework for system testing.
• Ensure all program milestones in support of all phases of the product development lifecycle are completed on time, with appropriate quality, and in compliance with relevant laboratory standards and regulations.
• Participate and/ or lead design reviews. Guide the team in the state of art V&V practices, QMS processes and on the applicable regulations / Standards, country specific requirements.
• Maintain an effective and collaborative working relationship with internal and external development partners across all levels and diverse cultures.
• Collaborate with other engineering teams within the organization.
• Guide, mentor, and provide direction to junior verification and validation Engineers.
• Ensure compliance to the product development process and Quality System requirements.
• Ensure good documentation are followed in the Verification and Validation Process.

Qualifications:

Bachelor\'s degree in mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field.

Education and/or Experience:

• Bachelor\'s degree in mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field
• 12 to 18 years of experience in Verification and validation testing of Software, hardware and System.
• Relevant technical testing/reliability experience in electro-mechanical, electrical, or software testing.
• Understanding of hardware and software product design methodologies and test practices.

Preferably having Functional experience / People Management experience

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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