Senior Manager, V&V, Respiratory Health

Job Description

Senior Manager, V&V, Respiratory HealthApply Now Save JobThis is where you save and sustain livesAt 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. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxters 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 s Respiratory Health business unit products expand therapies to better help patients andphysicians to manage chronic or acute respiratory and cardiac diseases (COPD, CHF, etc.). The earlier the treatment for these patients the better the quality of life. The $150M business portfolio includes products for airway clearance and ventilation. As the Senior Manager, Verification and Validation,you will be leading a team of Verification and Validation engineers to support Device Engineering development team of the Respiratory Health R&D team in Bangalore (BRD). You will be responsible for creating, ramping up and managing a team that aligns with the organizations 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 supportmainly in thesustaining engineering of airway clearanceDevices. 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 AssociateDirector for Respiratory Health division of Front Line Care.Essential Duties and Responsibilities :
• Manages a team of Verification and Validation engineers / first level Managers, 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.
• 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 toAssociate Director for Respiratory Health, you will be responsible for growing a team with the required engineering capabilities to support the Respiratory Health. Your team includes Verification and ValidationEngineers 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 AccommodationsBaxter 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 processRecruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.,

Keyskills :
financesalesltdmisaccountancynew product developmentmanage complex projectsverificationvalidationcontinuous improvement facilitationquality management systemsix sigma