Technical Manager

1 week ago

Bengaluru Pune, India Quest Global Full time US$ 1,50,000 - US$ 2,00,000 per year

Onsite Opportunity - Netherlands

Job Summary

We are seeking a Technical Manager with deep domain expertise in medical imaging hardware and systems. The selected candidate will lead technical engagements across the full product lifecycle, focusing on design, integration, compliance, and end-to-end lifecycle management of systems such as Diagnostic X-ray, Computed Tomography (CT), Image Guided Therapy (IGT), Mobile Surgery and Mammography Systems. This is a high-impact role requiring deep technical expertise and leadership, strong regulatory acumen, hands-on experience, and stakeholder management and project 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.

Work Experience

Essential Experience & Skills

  • Bachelors or masters degree in electrical, Electronics, Biomedical or Mechatronics streams
  • 18+ years of experience in medical device hardware engineering, specifically in diagnostic imaging modalities like Diagnostic X-ray, Computed Tomography (CT), Image Guided Therapy (IGT), Mobile Surgery and Mammography 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 and mentorship to 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 plus.

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