Job Requirements
The Senior Engineering Manager – Hardware and Systems will lead multi-disciplinary engineering teams to deliver end-to-end product development and sustaining engineering for global MedTech OEM clients. This role ensures that all engineering deliverables meet stringent performance, quality, regulatory and safety expectations while achieving on-time, on-budget, and first-time-right delivery as per Quest Global’s commitments. As a client-facing leader, the Engineering Manager collaborates closely with OEM stakeholders, drives execution excellence, ensures transparent communication, and fosters a culture of engineering rigor and continuous improvement.
Key Responsibilities:
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Own end‑to‑end delivery of hardware and systems engineering programs for global MedTech OEM clients.
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Lead technical planning, design, development, integration, and verification across the full product lifecycle.
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Own key technical decisions and provide clear technical direction and guidance to engineering teams.
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Ensure compliance with applicable regulatory, quality, and safety standards and drive First Time Right (FTR) quality of delivery.
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Establish strong governance for estimation, planning, risk & opportunity management, dependencies, and milestone reviews.
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Ensure on‑time, on‑budget, and KPI/SLA‑driven delivery aligned with Quest Global delivery frameworks.
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Oversee product lifecycle management (LCM), sustaining engineering, and disciplined engineering change processes.
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Act as the primary engineering interface and technical liaison with client R&D, architects, and cross‑functional stakeholders.
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Manage scope, change requests, and delivery expectations with transparency and professionalism.
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Build trusted, long‑term client relationships through technical credibility and execution reliability.
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Identify opportunities for value addition, continuous improvement, and scope expansion within client accounts.
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Support solutioning, estimations, proposal reviews, and technical responses in collaboration with program and solution teams.
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Build, mentor, and manage high‑performing teams of hardware, systems, reliability, and test engineers.
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Own performance management, skills assessment, career development, succession planning, and resource utilization.
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Enable continuous upskilling in MedTech regulations, tools, engineering best practices, and Quest Global processes.
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Foster a culture of quality, patient‑safety‑first thinking, accountability, and engineering excellence.
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Promote process compliance, audit readiness, and documentation rigor across programs.
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Drive standardization, reuse, and best‑practice adoption across programs.
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Leverage data and metrics to improve productivity, predict risks, and enhance delivery outcomes.
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Stay current with evolving MedTech technologies, standards, and regulatory expectations and embed them into team practices.
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Support Quest Global initiatives on engineering transformation, digital adoption, and operational efficiency.
Work Experience
- Bachelor’s or master’s degree in Electrical, Electronics, Mechanical, Biomedical or Mechatronics streams
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20+ years of experience in medical device hardware and system engineering, specifically in diagnostic imaging and critical care products/systems.
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Solid track record of leading hardware/system engineering activities in regulated environments.
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Good knowledge of international and regional regulatory frameworks and standards, including FDA, EU MDR, Other Country Specific Regulations, IEC 60601 series, ISO 13485 etc.
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Knowledge in regulatory submissions (e.g., FDA 510(k), EU Technical Documentation) etc.
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Proficient in working with PLM systems (e.g., Windchill, Teamcenter) and quality documentation platforms.
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Strong knowledge of safety standards, electrical and thermal risk controls, and human factors engineering.
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Deep understanding of design controls, risk management, verification & validation protocols and traceability matrices.
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Stay up-to-date with advancements in Medical Device technologies and regulatory changes
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Strong people leadership, mentoring, and organizational skills
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Excellent communication, articulation, and stakeholder management skills
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Structured, analytical problem‑solving and decision‑making capability
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High accountability, quality mindset, and customer orientation
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Experience working with Tier‑1 MedTech OEMs in imaging, patient monitoring, surgical, therapy, or lab diagnostics will be an added advantage.
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Understanding of global delivery models (onsite–offshore coordination) will be an added advantage.
