Eng II, Acute Disposables (Medical Devices)

Location: Bangalore, Karnataka, India; onsite

Company

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

What you will do

• Support R&D development and sustenance projects for acute therapy disposables, including injection-molded components and soft tubing.
• Plan and execute formal verification and validation, functional, performance, reliability, environmental, and design-of-experiments testing.
• Build test fixtures and assemblies, prepare test setups, develop test methods, and support laboratory logistics.
• Perform root cause analysis and troubleshoot unfavorable test outcomes and product failures.
• Manage change-control activities using Trackwise8 and Teamcenter Unified.
• Coordinate with internal stakeholders and external vendors on transport validation, stability, sterilization testing, test plans, and technical reports.

Requirements

• Diploma or bachelor's degree in mechanical engineering, biomedical engineering, polymer engineering, or a related engineering discipline.
• 4–8 years of overall experience, including at least 2 years in medical device verification testing focused on mechanical hardware or disposables.
• Knowledge of mechanics, thermodynamics, hydraulics, heat transfer, materials, mechanical and fluid-flow systems, and injection-molded components.
• Experience with laboratory management, laboratory controls, engineering test procedures, reliability testing, and internal or external audits.
• Understanding of medical device development, design verification and validation, risk management, reliability engineering, process validation, and system integration.
• Understanding of FDA, ISO, and IEC design-control requirements, quality systems, good documentation practices, and Good Manufacturing Practices.

Culture & Benefits

• Work within a cross-functional R&D and laboratory environment focused on improving patient care.
• Support instrument management, calibration, consumable tracking, laboratory safety, and compliance controls.
• Collaborate with senior subject-matter experts, R&D engineers, stakeholders, and external testing vendors.
• Reasonable accommodations are available for candidates with disabilities.