обновлено 6 дней назад
Principal Eng, Disposables (Medical Devices)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Principal Eng, Disposables (Medical Devices): Leading verification and validation, change control, and disposable manufacturing process development for medical devices with an accent on design controls, regulatory compliance, and test infrastructure. Focus on designing and executing complex studies, automating testing, qualifying laboratories and vendors, and closing audit findings.
Location: Bangalore, Karnataka, India
Company
develops vital organ therapy solutions, including kidney care technologies, digital solutions, and advanced medical services.
What you will do
- Own technical change control activities across development, sustaining projects, and design controls.
- Lead R&D studies and verification and validation activities, including product integration, system testing, and automated testing.
- Drive the development, improvement, and troubleshooting of disposable manufacturing processes.
- Plan and maintain test infrastructure, laboratories, equipment, budgets, and shared resources.
- Design fixtures, coordinate vendor qualification, and support manufacturing and cross-functional teams.
- Prepare, review, approve, and release test reports while managing timelines across multiple projects.
Requirements
- Bachelor’s or master’s degree in mechanical engineering or an equivalent technical discipline.
- 10–16 years of experience in systems- and component-level verification and validation.
- Deep knowledge of design verification and validation for medical devices.
- Technical testing or reliability experience with plastics, connectors, products, or electromechanical systems.
- Understanding of hardware test methodologies, best practices, quality systems, and regulatory expectations.
- Ability to analyze and solve complex problems, manage multiple projects, and collaborate with global cross-functional stakeholders.
Nice to have
- Hands-on experience with UTM, leak testers, torque testers, and similar mechanical testing equipment.
- Experience with RF welding, solvent bonding, medical device manufacturing processes, Minitab, or Six Sigma.
Culture & Benefits
- Mission-driven work focused on extending patients’ lives and improving care-team efficiency.
- Collaboration with internal and external stakeholders across levels and cultures.
- Participation in corporate, internal, ISO, and regulatory audits.
- Commitment to providing reasonable accommodations during the application and interview process.
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