Sr Eng, Disposables (Medical Devices)

Location: Bangalore, Karnataka, India

Company

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

What you will do

• Own change management activities for development and sustaining projects, including design control documentation, implementation, data management, lifecycle verification, and cross-functional coordination.
• Plan and execute R&D studies, product design verification, validation, reliability testing, and manufacturing-readiness activities for disposable products across multiple sites.
• Improve product test methods, technologies, and test automation to increase quality, efficiency, and productivity.
• Prepare and manage test protocols, final reports, FDRs, and DIRs through routing, review, sign-off, release, and closure.
• Lead IQ, OQ, and PQ activities for equipment and instruments, and represent the function during internal, ISO, corporate, and regulatory audits.
• Design fixtures for verification and validation needs, coordinate with external vendors, and collaborate with global cross-functional teams on project deliverables.

Requirements

• Bachelor’s or master’s degree in mechanical engineering or an equivalent technical discipline.
• 7–12 years of relevant experience in system- and component-level verification and validation.
• Experience in technical testing and reliability engineering for plastics, connectors, products, or electromechanical systems.
• Experience with medical device development, design verification and validation, system integration, risk management, process validation, and quality systems.
• Hands-on experience with equipment such as UTM, leak testers, torque testers, and other relevant instruments.
• Knowledge of hardware test methodologies, test best practices, regulatory standards, and medical device manufacturing processes.

Nice to have

• Exposure to RF welding and solvent bonding.
• Experience with Minitab and Six Sigma methods for results analysis.

Culture & Benefits

• Work focused on extending patients’ lives and improving care-team efficiency.
• Collaboration with global cross-functional teams.
• Commitment to reasonable accommodations for candidates and employees with disabilities.