Sr Mgr, Software V&V

3 weeks ago

Bengaluru, India Baxter Full time

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.

Summary

Sr Mgr, Software V&V is responsible for verification and validation of medical and non-medical software products in the Infusion Systems portfolio. 

Essential Duties and Responsibilities

Manages a team of Verification engineers / leaders, accountable for SW / product design verification and validation across multiple global digital products across the product development lifecycle.

As a functional leader, responsible for recruitment, team/talent development, skill set development, coaching & performance management.

Effectively leverages 3rd party vendors and partners for seamless execution of verification strategies

Leads a change through creative solutions adapting to the new product test methods andtechnologies and driving test automation to enhance the assured quality and productivity in testdeliverables.

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 with strong focus on meeting committed timelines.

Drives execution as a core strength in the team 

Plans, builds & maintains the test infrastructure, and manages the budget planning for the labs across sites.

Develops and maintains an effective and collaborative working relationship with internal and external partners across all levels and diverse cultures

Responsible for development of state-of-the-art industry expertise and technical competencies as well as effective deployment throughout a multi-site organization.

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. 

Adheres to Baxter Quality Management system and Represents the Management in Corporate audits, Internal audits, ISO audits and Regulatory audits.

Qualifications

Bachelors / Master's in Computer Science, Computer Engineering, Electrical Engineering, Software Engineering or related field. 

Experience should include at least 15+ years of relevant experience, including technical, program & functional leadership. 

At least 5 years of experience leading large verification teams (30+) in medical devices domain.

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, andstandards. 

Demonstrated experience in accomplishing objectives. Able to deliver multiple projects simultaneously and managing communication with global stakeholders. 

Work effectively with cross functional teams including quality, program management, service, regulatory, medical, and clinical. 

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.

Desirable experience

Prior experience launching multiple medical products in the global market is preferred.

Experience with ALM, DOORS, ClearQuest, TeamCenter and JIRA a plus.

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