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Provides functional leadership for Medication Delivery System Verification and Validation team.  Create and manage a department vision that aligns with the organization's vision or strategic plan. Build on the team structure to handle system verification and validation for multiple programs. Based on significant process and technical expertise, reviews and approves verification plans and methods and provides general direction to verification engineering staff. Ensures that quality is built into the design during new product development. Reports out on the progress to senior management.

Essential Duties and Responsibilities

• Functional management of System Verification & Validation Engineering staff.
• As a functional leader, responsible for recruitment, team/ talent development, skill set improvement, coaching & performance management, process development and be the subject matter expert
• Assess resources and team strengths and weaknesses and develop plans to achieve individual/team/department goals and objectives.
• Recommends changes to policies and establishes procedures that affect immediate department/function.
• Guide, mentor, and provide direction to Verification Engineers.
• Create opportunities to automate testing and optimize test processes. Leverage and enhance exiting automation framework for system testing.
• Participate in the system integration planning activities for all product lines. Engage in test planning during design and development phases.
• Create 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.
• Collaborate with third party labs and Contract house for the successful completion of Projects.  – Combine all collaborations with global teams, external labs, bullets into one?
• Ensures compliance to development processes and standard work requirements.
• Participates and/ or leads design reviews.  Guides the team in the state of art V&V practices, QMS processes and on the applicable regulations / Standards, country specific requirements.
• Identifying and setting up of facilities and equipment needed and necessary staff for successful execution of projects.
• Allocate resources and time required to conduct several verification and validation activities across multiple new product development projects and monitor the performance of these to ensure milestones are met.
• Develops and 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.
• Ensures good documentation and Good Manufacturing practices are followed in the Verification and Validation Process.
• Collaborates across multiple locations to leverage talent and processes effectively.  
• Actively communicates and advocates team’s capabilities and accomplishments.  
• Ensure compliance to the product development process and Quality System requirements.
• Collaborate with other engineering teams within the organization.

Qualifications

• Bachelor’s Degree in mechanical, Electrical, Computer Science, Biomedical Engineering or equivalent, MS preferred, with approximately 7+ years of relevant industry experience with a minimum of 3 years in relevant functional management capacity. 
• 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.
• Demonstrated experience working with vendors with different models of engagement.
• Knowledge of Design controls, lifecycle testing processes, MTBF analysis.
• Must have demonstrated effective supervisory and people development skills.
• Ability to lead teams across multiple sites

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.