Manager, V&V – Front Line Care

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—where your purpose accelerates our mission.

Your Role at Baxter:

Baxter provides a broad portfolio of essential hospital products, including home, acute; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services.

The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries.

Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

Baxter’s Front Line Care business is a 1.1B$ business comprising of Connected monitoring, Respiratory health, Cardiology, Intelligent diagnostic groups.  The products, used by clinicians in acute and ambulatory care settings globally.

As the Manager, Verification and Validation, you will be leading a team of Verification and Validation engineers to support Device Engineering development team of the FLC R&D team in Bangalore (BRD).

You will be responsible for creating, ramping up and managing a team that aligns with the organization's vision or strategic plan. You will be responsible to recruit and build the complete team and drive the transfer of select product support ownership to support mainly in the sustaining engineering of airway clearance Devices.

You will possess solid “hands-on” technical abilities, an excitement and energy for product Verification & Validation and a passion for their work and the impact it has on meeting the needs of customers. You will be expected to, based on significant technical expertise, review and approve V&V methods and provides general direction to technical staff. Utilize solid understanding of theories and practices of a variety of disciplines to manage complex projects or programs within boundaries of quality, time, and budget. You will be acknowledged outside of business unit or division for input on programs of some magnitude. Need to exhibit creativity and innovation in completing divisional and cross-functional/business unit responsibilities.

You and your team will work with global cross functional teams located across the globe. Your team, as it grows in capability, will be expected to take on growing responsibilities for legacy products, peripherals, and strategic New Product Development activities.

This position is based out of Bangalore and reporting to the Associate Director Front Line Care.

Essential Duties and Responsibilities:

• Manages a team of Verification and Validation engineers, accountable for SW / product design verification and validation across multiple sites across the product development lifecycle
• As a functional leader, responsible for recruitment, team/talent development, skill set development, coaching & performance management
• Leads a change through creative solutions adapting to the new product test methods and technologies and driving test automation to enhance the assured quality and productivity in test deliverables
• Partners with R&D functionals / cross functional teams to coordinate Integration and System testing of products including automated testing.
• Drives the V&V function to ensure meeting the customer requirements, safety, regulatory and quality needs at a committed timeline
• Plans, builds & maintains the test infrastructure, and manages the budget planning for the labs across sites.
• Drive test automation activities and Continuous improvement in V&V function
• Ability to develop optimum test strategy for execution of V&V function
• Technically guide and mentor the team members towards better performance
• Ability to front end audits (Internal & External)
• Responsible for development of state-of-the-art industry expertise and technical competencies as well as effective deployment throughout a multi-site organization.  
• Develops and maintains an effective and collaborative working relationship with internal and external development partners across all levels and diverse cultures
• Foster an environment where mentoring, coaching, career growth and progression, and employee development are critical focus areas.
• Actively communicate and advocate team’s capabilities and accomplishments.
• Responsible for development of state-of-the-art industry expertise and technical competencies as well as effective deployment throughout a multi-site organization.
• Adheres to Baxter Quality Management system and Represents the Management in Corporate audits, Internal audits, ISO audits and Regulatory audits.

Your Team:

Reporting directly to Associate Director, you will be responsible for growing a team with the required engineering capabilities to support the FLC Business. Your team includes Verification and Validation Engineers of varying level of qualification and experience.

Your Location:

The role is located in the BRD facility in Bangalore India. 

What You’ll Bring:

• Bachelor’s/Master’s degree in Computer Science, Electrical, Electronics, Mechanical, Biomedical engineering, or equivalent relevant technical degree.
• Experience should include at least 15+ years of relevant technical experience, including technical & functional leadership.
• At least 5 years of formal functional leadership experience.
• Demonstrated experience in leading technical teams, preferably in managing product development teams in a matrix global organization.
• Experience in medical device product development, design verification/validation, system integration (involving software & hardware), risk management, reliability engineering, process validation and Quality systems.
• Deep domain knowledge in design verification and validation of medical devices.
• Understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards.
• Demonstrated experience in accomplishing objectives. Able to deliver on multiple projects simultaneously.
• Experience with DOORS and JIRA a plus.
• Work effectively with cross functional teams including quality, program management, manufacturing, regulatory, medical, and clinical.
• Exposure to Six Sigma methodologies like DFSS, DFM, DFR etc. is a plus
• Medical device, diagnostics, laboratory testing product experience or similar products is preferred. 
• Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.
• Self-motivated with good interpersonal skills.
• Capable of analyzing and solving complex problems through innovative thought and experience. Ability to design and influence outside of immediate scope of responsibility.
• Understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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