Engineering Manager
14 hours ago
Description :Essential Duties & Responsibilities :Leadership & People Management :- Manage and mentor a cross-functional engineering team (20+ members across SW, FW & Systems).- Strong experience in team building, talent management, conflict resolution and stakeholder management.- Blend of people management + technical leadership; proven experience delivering end-to-end product solutions.- Develop junior engineers through coaching, empowerment, reviews and soft-skill development.Product Development & Technical Expertise :- Extensive experience in distributed product development and global team collaboration.- Deep understanding of product development processes & key medical device regulations:- IEC 60601, IEC 62304, ISO 13485, ISO 14971.- Strong knowledge of design controls for medical devices.- Hands-on understanding of embedded systems, real-time systems, application development and architecture.- Solid experience in systems engineering, C#/C++, Python scripts and modern software practices.- Strong exposure to AI/ML integration and Test Automation.- Ability to define needs and build capabilities across SW development, V&V, and turnkey solution areas.Process, Quality & Standards :- Expertise in Agile & Waterfall methodologies with ability to define SW metrics and improve processes.- Maintain deep knowledge of technology stack, tools, solution architecture and drive POCs at MEIC.- Stay updated and establish compliance with relevant healthcare technology standards- (DICOM, HL7, IEC 62304, ISO 11073, etc.).Business & Strategic Responsibilities :- Support organic, blended & inorganic global product development programs.- Contribute to technology roadmap, pitch proposals for technology development and turnkey initiatives.- Support regional growth by tailoring products for specific markets (in-country for country).- Identify capability gaps and plan for strategic partnerships or internal competency building.Principal Working Relationships :- Work closely with the PMO to ensure accurate resource forecasting and project metric reporting.- Collaborate regularly with cross-functional engineering teams to meet project schedules.- Interact with clinicians, third-party vendors, manufacturers and subcontractors as needed.Required Experience :- 17+ years in product development.- 10+ years in medical device development & verification (mandatory).- Proven track record of managing multi-disciplinary engineering teams in FW/HW/SW environments.Knowledge, Skills & Abilities :- Strong technical background in systems engineering, C#/C++, real-time systems, Python scripting.- Thorough knowledge of design controls (CFR 820.30), 510k, IEC 62304 and related standards.- Experience in device communication, diagnostics, databases & latest communication protocols.- Hands-on experience across entire SDLC from requirements to deployment.- Experience incorporating AI/ML capabilities into medical device products.- Strong leadership abilities aligned with mid-level leadership expectations. (ref:hirist.tech)
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