Technical Manager

5 days ago

Pune, Maharashtra, India Quest Global Full time ₹ 1,04,000 - ₹ 1,30,878 per year

Job Requirements

Job Description: Sr. Technical Manager Job Summary

We are seeking a Sr. Technical Manager with deep domain expertise in medtech products and devices. The selected candidate will lead technical engagements across the full product lifecycle, focusing on design, integration, compliance, and end-to-end lifecycle management of diagnostic imaging and critical care products/systems. This is a high-impact role requiring deep technical expertise and leadership, strong regulatory acumen, hands-on experience, and stakeholder management in complex medical hardware systems.

Key Responsibilities

  • Lead technical planning, development, and integration testing of imaging hardware systems.
  • Oversee product lifecycle management (LCM) and engineering change processes for medical imaging platforms.
  • Act as the technical liaison between the R&D and cross-functional teams of the client and engineering teams of Quest Global.
  • Ensure that product development and updates comply with applicable regulatory, quality, and safety standards, including FDA, EU MDR, IEC norms etc.
  • Own and maintain Design History Files (DHFs), Risk Management Files (RMFs), Device Master Records (DMRs), and Technical Files.
  • Lead Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), and other hazard mitigation efforts.
  • Manage Verification and Validation (V&V) of hardware components and systems in compliance with regulatory standards.
  • Conduct and support the failure investigation, root cause analysis (RCA) and Corrective and Preventive Action (CAPA) processes for field issues.
  • Drive design decisions using risk-based approaches and ensure alignment with clinical use cases and intended use.
  • Facilitate client audits, internal quality reviews, and regulatory inspections as needed.
  • Own Technical Decisions; Provide Technical Guidance and Direction
  • Accountable for issue closure as per the committed leadtime with customer
  • Ensure Quality of Delivery - First Time Right (FTR)

Work Experience

Essential Experience & Skills

  • Bachelor's or master's degree in electrical, Electronics, Biomedical or Mechatronics streams
  • 18+ years of experience in medical device hardware 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.
  • Experience 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.
  • Provide technical leadership, skill development, mentoring and handholding of junior engineers.
  • Stay up-to-date with advancements in Medical Device technologies and regulatory changes
  • Excellent communication and articulation skills
  • Strong analytical and problem-solving abilities

Desirable Experience & Skills

  • Ability to interact with Notified Bodies, FDA inspectors, and regulatory consultants.
  • Exposure to post-market surveillance, UDI implementation, and real-world evidence (RWE) reporting.
  • Experience with audit readiness, remediation projects, or FDA consent decree programs is a plu

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