Risk Management Specialist (Medical Devices)

Staffing Services; Bengaluru; In loco; INR 1.200.000 - 1.800.000; Tempo pieno

Descrizione del lavoro

Staffing Services is seeking an experienced risk management professional for medical device development. You will develop risk management plans in accordance with ISO 14971 and FDA QSRs, lead FMEA activities, and drive risk mitigation across hardware and software components.

Collaborating with design, regulatory, clinical and quality teams, you will ensure traceability, documentation and audit-ready records to support product lifecycle risk controls.

Competenze

• Experience in medical device development with risk management focus.
• Strong knowledge of ISO 14971, IEC 60601, ISO 13485, and FDA QSRs.
• Good technical writing and documentation skills.

Mansioni

• Develop and maintain risk management plans, procedures and frameworks in line with ISO 14971.
• Lead risk analyses (FMEA, design FMEA, use FMEA) and risk mitigation.
• Collaborate with design, regulatory and quality teams across the product lifecycle.
• Maintain risk files, traceability matrices and risk-benefit analyses.
• Ensure compliance with IEC 60601, ISO 80601 and ISO 14971 standards.

Conoscenze

Risk management

Regulatory compliance

Documentation

Analytical skills

Communication

Formazione

MTech/ME/BTech/BE in Biomedical/Electrical/Mechanical/Systems Engineering

Strumenti

IBM DOORS

Windchill

Descrizione del lavoro

• Develop and maintain risk management plans, procedures, and frameworks in compliance with ISO 14971.
• Ensure risk management activities align with FDA 21 CFR Part 820.30 and ISO 13485 design control requirements.
• Lead comprehensive risk analysis and mitigation for o Hazard identificationo Design FMEA (dFMEA)o Use FMEA (uFMEA)o Product risk analysis and control
• Integrate risk controls into the design and development process to ensure safety and compliance.
• Collaborate with design, clinical, regulatory, and quality teams to assess and mitigate risks throughout the product lifecycle.
• Provide risk-related input during design reviews, change control boards, and technical discussions.
• Create and maintain risk files, traceability matrices, and risk-benefit analyses.
• Ensure compliance with IEC 60601, ISO 80601 and ISO 14971 standards for electromechanical and respiratory devices.
• Maintain clear, audit-ready documentation of risk assessments and mitigation strategies.
• Participate in internal and external audits, representing risk management documentation and processes.
• Experience with requirements and traceability tools such as IBM DOORS and Windchill.Education & Skills preferred:
• MTech / ME / BE / BTech in Biomedical, Electrical, Mechanical, Systems Engineering, or related field. 610 years of experience in medical device development, with at least 4-5 years focused on risk management.
• Strong understanding of ISO 14971, IEC 60601, ISO 13485, and FDA Quality System requirements
• Experience with electromechanical systems and respiratory therapy devices is highly preferred.
• Strong analytical, documentation, and communication skills.