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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

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Position Overview

As a Senior Engineer, contributes to System Verification Engineering vision that aligns with the organization's vision and strategic plan.  Utilizes 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. Exhibits creativity and innovation in completing divisional and cross-functional/business unit goals and objectives. Contribute to the plans and leads project assignments in the evaluation, selection and adaptation of various techniques, procedures, and criteria with minimal guidance. Ensures that quality is built into the design during new product development.

Essential Duties and Responsibilities

• Contributes to technical direction for Systems Verification and Validation Engineering staff and programs.
• Contributes to the planning, development and execution of system verification and validation deliverables (test plans, test protocols, test cases, test reports, studies). Engage in test planning during design and development phases.
• Contributes to the development and documentation of system requirements, systems architecture and design.
• Ensure appropriate traceability between system, subsystem, verification/validation and cross functional deliverables.
• Manages the integration of deliverables from subsystem teams, cross functional teams (risk management, compliance, etc.) and external partners.
• Resolves competing constraints between interrelated functions (Engineering, Risk Management, Compliance, Reliability, Clinical, Human Factors, Regulatory)
• Implementing configuration and change management through the complete product life-cycle, including verification and validation deliverables.
• Recommends changes to policies and establishes procedures that affect immediate department/function.
• Creates best practices and process improvements to streamline testing between system verification, subsystem and software verification.
• Ensures 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.
• Participates and/ or leads design reviews.  
• Maintains an effective and collaborative working relationship with internal and external development partners across all levels and diverse cultures.
• Guides the team in investigations for identifying the root cause and drives action to prevent such issues recurring.
• Collaborates with other engineering teams within the organization.
• Guide, mentor, and provide direction to junior verification and validation Engineers.
• Ensures compliance to the product development process and Quality System requirements.
• Ensures good documentation and Good Manufacturing practices are followed in the Verification and Validation Process.

Qualifications

• Bachelor’s Degree in mechanical, Electrical, Computer Science, Biomedical Engineering or equivalent, MS preferred, with approximately 3+ years of relevant industry experience.
• Healthcare industry experience preferred.
• Requires strong organization and communication skills, with the ability to interface with both technical and non-technical personnel. 
• Strong knowledge of ISO, FDA and other regulatory standards is essential.
• Knowledge of Design controls, lifecycle testing processes, MTBF analysis.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                               
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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.