Technical Manager

• 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

• 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

• 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

Quest Global