Overview
Lead system design and systems engineering activities for next-generation medical devices, from concept through commercialization and operation support.
What you'll do
- Lead systems engineering for development of next-generation medical devices.
- Define system requirements, architectures, interfaces, and end-to-end workflows across hardware, software, cloud, and connectivity.
- Own requirements management and traceability from user/stakeholder/regulatory/product inputs to system-level requirements.
- Perform system architecture and design trade-off analysis across performance, usability, cybersecurity, safety, reliability, scalability, serviceability, cost, and regulatory compliance.
- Lead risk management activities in accordance with ISO 14971, including hazard analysis and verification of risk mitigations.
- Drive design reviews for phase gates and regulatory submissions, partnering with Verification & Validation teams on V&V strategies.
- Oversee design control deliverables including Design History Files (DHF) and related system documentation.
What you'll need
- Minimum 5+ years of experience in systems engineering, product development, or technical leadership roles for complex products.
- Bachelor's or Master's degree in systems engineering, electrical engineering, computer engineering, software engineering, biomedical engineering, or a related discipline.
- Experience developing regulated products using formal design controls and quality management processes.
- Strong understanding of medical device development lifecycle, including requirements engineering, architecture, risk management, verification/validation, and product release.
- Experience working with multidisciplinary engineering teams across hardware, software, systems, and cloud technologies.
- Knowledge of global medical device standards and regulations including ISO 13485, ISO 14971, IEC 62304, and IEC 62366.
Details
- Location: IND19-01-Bengaluru-EPIP 122 (Phase II).
- Relocation assistance provided: No.
Read the full description and apply on the company’s own careers page.
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