Senior Engineering Manager - Hardware and Systems

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:

• Own endtoend delivery of hardware and systems engineering programs for global MedTech OEM clients.
• Lead technical planning, design, development, integration, and verification across the full product lifecycle.
• Own key technical decisions and provide clear technical direction and guidance to engineering teams.
• Ensure compliance with applicable regulatory, quality, and safety standards and drive First Time Right (FTR) quality of delivery.
• Establish strong governance for estimation, planning, risk & opportunity management, dependencies, and milestone reviews.
• Ensure ontime, onbudget, and KPI/SLAdriven delivery aligned with Quest Global delivery frameworks.
• Oversee product lifecycle management (LCM), sustaining engineering, and disciplined engineering change processes.
• Act as the primary engineering interface and technical liaison with client R&D, architects, and crossfunctional stakeholders.
• Manage scope, change requests, and delivery expectations with transparency and professionalism.
• Build trusted, longterm client relationships through technical credibility and execution reliability.
• Identify opportunities for value addition, continuous improvement, and scope expansion within client accounts.
• Support solutioning, estimations, proposal reviews, and technical responses in collaboration with program and solution teams.
• Build, mentor, and manage highperforming teams of hardware, systems, reliability, and test engineers.
• Own performance management, skills assessment, career development, succession planning, and resource utilization.
• Enable continuous upskilling in MedTech regulations, tools, engineering best practices, and Quest Global processes.
• Foster a culture of quality, patientsafetyfirst thinking, accountability, and engineering excellence.
• Promote process compliance, audit readiness, and documentation rigor across programs.
• Drive standardization, reuse, and bestpractice adoption across programs.
• Leverage data and metrics to improve productivity, predict risks, and enhance delivery outcomes.
• Stay current with evolving MedTech technologies, standards, and regulatory expectations and embed them into team practices.
• Support Quest Global initiatives on engineering transformation, digital adoption, and operational efficiency.

• Bachelor's or master's degree in Electrical, Electronics, Mechanical, Biomedical or Mechatronics streams
• 20+ years of experience in medical device hardware and system engineering, specifically in diagnostic imaging and critical care products/systems.
• Solid track record of leading hardware/system engineering activities in regulated environments.
• Good knowledge of international and regional regulatory frameworks and standards, including FDA, EU MDR, Other Country Specific Regulations, IEC 60601 series, ISO 13485 etc.
• Knowledge in regulatory submissions (e.g., FDA 510(k), EU Technical Documentation) etc.
• Proficient in working with PLM systems (e.g., Windchill, Teamcenter) and quality documentation platforms.
• Strong knowledge of safety standards, electrical and thermal risk controls, and human factors engineering.
• Deep understanding of design controls, risk management, verification & validation protocols and traceability matrices.
• Stay up-to-date with advancements in Medical Device technologies and regulatory changes
• Strong people leadership, mentoring, and organizational skills
• Excellent communication, articulation, and stakeholder management skills
• Structured, analytical problemsolving and decisionmaking capability
• High accountability, quality mindset, and customer orientation
• Experience working with Tier1 MedTech OEMs in imaging, patient monitoring, surgical, therapy, or lab diagnostics will be an added advantage.
• Understanding of global delivery models (onsite-offshore coordination) will be an added advantage.