Senior Manager, FLC

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At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.

Here you will find more than just a jobyou will find purpose and pride.

Baxters Front Line Care business products expand Diagnosis & Therapies in the context of connected monitoring cardiology and respiratory health. The earlier the diagnosis & treatment for these patients the better the quality of life. The $1.2B business portfolio includes products for Cardiology Patient monitoring airway clearance ventilation and Intelligent diagnostics. As a Senior Manager Hardware & Systems Verification you will lead a multidisciplinary organization spanning Electrical/Electronic Engineering & System Verification & Validation (V&V) for electro-mechanical medical devices. This is a strategic leadership role aimed at expanding technical and organizational breadth across: Hardware design (electrical mechanical) Embedded systems and controls integration System-level verification validation and quality assurance. You will drive end-to-end product realization influencing: Sustenance engineering and product lifecycle management & New Product Development (NPD) from concept through commercialization Innovation and technology strategies. You will collaborate with global cross-functional teams to deliver safe compliant high-quality medical devices while shaping the future of R&D capabilities.

Essential Duties and Responsibilities:

1. Organizational & Strategic Leadership

• Define and execute the strategy for Hardware and Systems Verification functions aligned with business and product roadmaps.
• Build scale and lead high-performing teams across Electrical Mechanical and V&V engineering disciplines.
• Drive organizational capability development including talent pipeline succession planning and competency building.
• Influence global R&D strategies technology roadmaps and engineering best practices.
• Act as a technical and functional leader recognized across business units for programs of significant impact

2. Product Development & Lifecycle Ownership

• Lead and oversee end-to-end product development lifecycle:
  • Concept development
  • Architecture definition
  • Detailed design
  • Verification & validation
  • Transfer to manufacturing
  • Post-market sustainment
• Ensure successful delivery of complex electro-mechanical systems integrating hardware embedded software and controls.
• Drive sustenance engineering including root cause investigations field issue resolution and product enhancements.
• Partner with Program Management to ensure delivery within quality cost and schedule targets.

3. Hardware Engineering Leadership

• Provide technical oversight across:
  • Electrical systems (mixed-signal power electronics sensors control systems)
  • Mechanical systems (structural design fluid management plastics disposables simulation)
• Review and approve complex system architectures and design concepts across disciplines.
• Drive design for reliability manufacturability serviceability and cost optimization.
• Ensure robust integration of mechanical electrical and software subsystems.

4. System Verification & Validation Excellence

• Establish and lead comprehensive V&V strategy across product lifecycle:
  • Requirements traceability
  • Design verification
  • System validation
  • Integration and system testing
• Drive automation of test systems and infrastructure to improve quality and productivity.
• Ensure compliance with safety regulatory and quality requirements.
• Oversee test lab infrastructure tools and budgets.
• Represent R&D in audits (internal ISO regulatory) and ensure adherence to QMS.

5. Cross-Functional & Global Collaboration

• Partner with Quality Regulatory Manufacturing Clinical and Program Management teams globally.
• Drive effective multi-site collaboration and resource utilization.
• Engage with external partners suppliers and development collaborators.
• Drive Scalability and Governance of Activities with external partners suppliers and collaborators

6. Innovation & Strategic R&D Initiatives

Lead and champion strategic initiatives such as:

• Digital engineering / Digital twins for design and validation acceleration
• Test automation and AI-driven validation approaches
• Design for Six Sigma (DFSS) Reliability Engineering (DFR) and Cost Engineering (DFC)
• Modular platform development and reuse strategies
• Early-stage technology incubation and feasibility programs
• Integration of advanced sensing connectivity and control systems

7. Quality Compliance & Risk Management

• Ensure adherence to FDA ISO IEC standards and design control processes.
• Lead risk management activities (FMEA hazard analysis reliability assessments).
• Drive process validation and continuous improvement initiatives.

Qualifications:

• Bachelors or Masters degree in Electrical/Electronics OR Mechanical OR Biomedical Engineering or related field.

Experience & Competencies:

Experience

15 years of experience in medical device or complex electro-mechanical product development

5 years in functional leadership roles managing multi-disciplinary teams

Proven experience in global matrixed R&D environments.

Core Competencies

Technical Expertise

o Strong knowledge of:

Electrical systems (electronics embedded control systems). Mechanical systems (materials fluids structures plastics). System integration and verification methodologies

o Deep expertise in electro-mechanical system design and integration

Leadership & Strategic Skills

o Strong people leadership coaching and organizational development skills

o Ability to define and execute R&D strategies and influence senior stakeholders

o Expertise in decision-making under ambiguity and complex problem-solving

o Strong communication and stakeholder management skills

Process & Domain Knowledge

o Knowledge of: Regulatory standards (FDA ISO IEC) Quality systems and design controls GMP validation and manufacturing processes

• Demonstrated experience in accomplishing objectives. Able to deliver on multiple projects simultaneously.

• 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

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.

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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