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Senior Engineering Manager – Hardware and Systems

Quest Global -
Pune, Maharashtra

Quick apply

Job details

Full-time

Qualifications

Succession planning
Performance management
Master's degree
Electrical experience
Bachelor's degree
Risk management
Communication skills
FDA regulations

Full job description

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:

Own end‑to‑end 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 on‑time, on‑budget, and KPI/SLA‑driven 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 cross‑functional stakeholders.
Manage scope, change requests, and delivery expectations with transparency and professionalism.
Build trusted, long‑term 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 high‑performing 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, patient‑safety‑first thinking, accountability, and engineering excellence.
Promote process compliance, audit readiness, and documentation rigor across programs.
Drive standardization, reuse, and best‑practice 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.

Work Experience

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 problem‑solving and decision‑making capability
High accountability, quality mindset, and customer orientation
Experience working with Tier‑1 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.

Quick apply

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