Senior R&D Manager

Job Title: R&D Manager (ISO 13485 – Medical Devices)

Location: M46, Sultanpur(V),Telangana
Experience: 6+ years in Medical Device Quality Management
Industry: Medical Devices
Employment Type: Full-time
Salary: Based on interview performance

Key Responsibilities:

• Lead and manage the R&D team in the design, development, and continuous improvement of medical devices in compliance with ISO 13485 and other applicable regulations.
• Ensure all R&D activities meet regulatory and quality standards, including MDR/IVDR, ISO 14971, and US FDA (as applicable).
• Oversee the product development lifecycle from concept through commercialization, including design control, risk management, and verification & validation.
• Maintain and update Design History Files (DHF), Device Master Records (DMR), and Technical Documentation aligned with the Quality Management System (QMS).
• Collaborate with cross-functional teams such as Quality Assurance, Regulatory Affairs, Manufacturing, and Marketing to ensure cohesive product development.
• Conduct design reviews and phase-gate meetings to evaluate technical progress, manage risk, and resolve design challenges.
• Provide support during internal/external audits, manage CAPAs, and conduct investigations of non-conformities related to R&D activities.
• Drive innovation and technology roadmaps in alignment with strategic business objectives.
• Ensure proper documentation, traceability, and archival of protocols, test reports, and design outputs.
• Coach, mentor, and manage the R&D team, fostering a culture of innovation, quality, and regulatory compliance.

Qualifications:

• Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, or a related field.
• 7–10 years of hands-on experience in R&D within the medical device industry.
• Deep understanding and working experience with ISO 13485, ISO 14971, and design control processes.
• Proven ability in project management, cross-functional collaboration, and team leadership.
• Experience in preparing technical documentation, including CE Marking and FDA 510(k)/PMA submissions is a plus.

Preferred Skills:

• Proficiency in SolidWorks, CAD, and Finite Element Analysis (FEA) tools.
• Strong analytical and problem-solving skills.
• Knowledge of Good Manufacturing Practices (GMP) and usability engineering (IEC 62366).
• Experience working in multi-disciplinary, global, or matrixed environments.

Job Type: Permanent

Benefits:

• Health insurance
• Provident Fund

Schedule:

• Day shift

Work Location: In person