Senior Staff Systems Designer

Overview

Senior Staff Systems Designer responsible for end-to-end systems engineering of digital cardiovascular ultrasound products across the product development lifecycle, aligning customer workflows, product functionality, quality, reliability, serviceability, manufacturability, regulatory compliance and cost objectives.

What you'll do

• Lead end-to-end systems engineering activities for digital cardiovascular ultrasound products, from concept through commercialization and post-market support.
• Own the definition, development and delivery of product features and clinical applications, including requirements management, architecture development, design analysis, integration, verification, validation and risk management.
• Drive technical risk identification and retirement while ensuring compliance with applicable quality, regulatory, cybersecurity and safety requirements.
• Lead cross-functional development teams across engineering, clinical, quality, regulatory, product management, manufacturing, service and marketing organizations.
• Ensure effective requirements flow-down and traceability from customer and clinical needs to subsystem and component-level specifications.
• Conduct system design trade-off analyses and make data-driven decisions balancing performance, reliability, manufacturability, serviceability, scalability and cost.
• Lead design control activities including FMEA, hazard analysis, verification and validation planning, reliability testing, defect prevention, and corrective and preventive actions (CAPA).
• Serve as the primary systems engineering representative for internal and external audits, regulatory submissions, product reviews and compliance activities.
• Provide technical leadership and mentoring to systems engineering teams, influencing program priorities, development strategies and execution plans across multiple product generations.
• Collaborate closely with global stakeholders to resolve complex technical challenges, manage dependencies across subsystems, and ensure seamless product integration and customer satisfaction.
• Support manufacturing, field service and customer issue resolution, driving root cause analysis and continuous product improvement.

What you'll need

• Bachelor's or master's degree in engineering, Computer Science, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related STEM discipline.
• Minimum of 8+ years of engineering work experience in product development.
• Minimum of 6+ years of experience with systems engineering, product development and design control processes within the medical device or healthcare technology industry.
• Strong understanding of medical device development lifecycle, requirements management, risk management, verification and validation, and regulatory compliance.
• Experience leading cross-functional product development teams and complex technical programs.
• Knowledge of system architecture, subsystem integration, software-hardware interactions, and clinical workflow development.
• Strong analytical, problem-solving, communication and stakeholder management skills.
• Strong knowledge of SDLC, PRD process, risks and FMEAs.
• Awareness of patient-data privacy, cybersecurity and secure handling of clinical information.
• Experience with cloud-native and hybrid cloud/on-premises product development using AWS services.
• Experience with containers, Kubernetes, CI/CD, Infrastructure as Code and production observability.
• Experience with secure engineering, identity and access management, encryption, secrets management and DevSecOps.
• Experience with performance, scalability, availability, reliability, fault tolerance and disaster recovery.
• Experience with automated unit, integration, API, system, performance and reliability testing.
• Strong design, coding, debugging, root-cause analysis and technical documentation practices.
• Experience addressing integration challenges of third party and second party SaaS solutions.
• Experience working with AI-DLC and software development acceleration.

Nice to have

• Demonstrated experience in systems engineering methodologies in healthcare product development.
• Expertise in FMEA, reliability engineering and healthcare quality management systems.
• Demonstrated experience successfully leading new product introductions and multi-generational product development programs.
• Working knowledge of FDA, MDR, IEC 60601, IEC 62304, ISO 14971 and related medical device standards.
• Proven ability to influence technical strategy, mentor engineering teams and drive execution across global organizations.
• Experience in regulated healthcare or medical-device development.
• Knowledge of healthcare interoperability standards such as DICOM, HL7 and FHIR.
• Experience with real-time clinical data, device connectivity, patient monitoring or high-availability clinical applications.

Details

• Location: Bengaluru, India (EPIP 122, Phase II).
• Relocation assistance: not provided.