Senior Engineer, Systems C&S (Medical Devices)

Location: Bangalore, Karnataka, India

Company

hirify.global develops healthcare products and therapies for respiratory, cardiac, and patient-monitoring applications.

What you will do

• Define customer needs, system functions, performance, usability, and safety requirements for electro-mechanical medical devices.
• Manage system requirements and their decomposition into modules using DOORS and Excel.
• Execute compliance testing and support verification and validation activities throughout the product lifecycle.
• Lead product integration, identify integration issues, and support successful module and system development.
• Lead compliance with IEC 60601-1 and related standards, including product approvals, certifications, and type approvals.
• Maintain technical files, declarations of conformity, and regulatory documentation while supporting notified-body audits and regional registrations.

Requirements

• Bachelor’s degree in mechanical, electrical, electronics, software, computer science, biomedical, industrial engineering, or a related field.
• 3–8 years of experience in codes and standards, testing, and systems engineering for electro-mechanical system design.
• Experience developing medical devices and working with FDA regulations, MDR, ISO, and IEC design-control procedures.
• Strong knowledge of medical-device safety standards, including IEC 60601-1 and collateral standards, as well as IEC 62304, EMI/EMC, REACH, RoHS, and biocompatibility requirements.
• Experience with risk management under EN ISO 14971 and exposure to usability engineering processes.
• Strong collaboration, documentation, prioritization, and problem-solving skills, with the ability to support multiple projects simultaneously.

Culture & Benefits

• Work aligned with hirify.global’s mission to save and sustain lives.
• Collaborative environment focused on ownership, trust, accountability, and meaningful impact.
• Equal employment opportunity and reasonable accommodations are provided during the application and interview process.