Principal Eng, Risk (Medical Devices)

Location: Bangalore, Karnataka, India

Company

hirify.global develops vital organ therapy products and digital solutions, with a focus on kidney care, dialysis, and advanced medical services.

What you will do

• Lead risk management activities across the product lifecycle, from new product development through post-market surveillance.
• Perform ongoing risk analysis, identify mitigations, and help define risk-based requirements and verification and validation testing.
• Drive completion of risk management activities through design transfer and commercialization.
• Provide technical leadership and subject matter expertise to product development teams.
• Create and approve Design History File deliverables related to risk management.
• Coordinate FMEA, reliability, risk management, and cross-functional project activities across engineering, manufacturing, and service organizations.

Requirements

• BS or MS degree in Engineering.
• Approximately 7–10 years of practical electromechanical medical device design experience, or 5–7 years with an MS degree.
• Experience leading risk management activities for at least one significant project and managing complex projects.
• Working knowledge of medical device regulations, design controls, documentation controls, risk management, and validation.
• Understanding of ISO 13485, ISO 14971, IEC 60812, IEC 61025, IEC 62366, IEC 60601, IEEE-1633, and related standards.
• Excellent written and verbal English communication skills are required.

Nice to have

• Six Sigma Green Belt or Black Belt (DFSS) certification.
• LEAN certification.
• Membership in or certification from a professional organization such as INCOSE.

Culture & Benefits

• Work focused on improving patient lives and advancing vital organ therapies.
• Collaboration across engineering, manufacturing, service, and product development functions.
• Environment emphasizing continuous improvement, consistency, accuracy, and effective documentation.
• Reasonable accommodations are available for candidates with disabilities during the application and interview process.