Sr. Associate I – Research & Development, Process & Product Design
Job Requisition ID: R-2026-44523
Job Type: Full-Time, Permanent
Location: Bangalore, Karnataka, India
Application Deadline: February 27, 2026
About Alcon:
Alcon is a global leader in eye care, committed to advancing medical devices and software solutions that enhance vision and improve patient outcomes worldwide. With a culture of innovation, inclusion, and continuous development, Alcon provides opportunities to work on cutting-edge medical technologies that transform eye care.
Position Overview:
The Sr. Associate I – R&D Process & Product Design plays a critical role in medical device and software development, applying Design Control and Risk Management principles to ensure regulatory compliance, product safety, and quality. This includes Software in a Medical Device (SiMD), Software as a Medical Device (SaMD), and non-clinical software applications supporting Alcon instruments and solutions.
Key Responsibilities:
Develop and maintain Design History Files (DHFs) and Risk Management Files (RMFs) to support regulatory submissions, global product launches, and audit readiness.
Serve as a Subject Matter Expert (SME) on design control and risk management standards, including FDA 21 CFR 820.30, ISO 13485, ISO 14971, IEC 62304, IEC 60601, European MDD/MDR, MDCGs, and Alcon Quality System.
Plan, execute, and oversee design control deliverables in collaboration with project teams, including Design Plans, Design Inputs, Traceability Matrices, Verification and Validation Plans, and Design Review Reports.
Lead Design Phase Reviews, ensuring documentation clearly demonstrates compliance with design plans, risk mitigation, and regulatory requirements.
Champion systematic requirement management, maintaining traceability from design inputs to outputs, verification, validation, and risk management.
Drive risk management processes, including usability, hazard analysis, FMEA/FTA, benefit-risk evaluation, and residual risk disclosure, in coordination with technical and medical experts.
Coach cross-functional teams on effective application of design control, risk management, product security, and usability engineering best practices.
Continuously improve design control and risk management processes, ensuring alignment with global standards and regulatory expectations.
Required Experience & Skills:
5–7 years of experience in medical device product development (electrical, mechanical, optical, software).
Hands-on experience with design control for medical devices (21 CFR 820.30, ISO 13485, MDD/MDR).
Proficient in risk management for medical devices (ISO 14971).
Experience with software development for medical devices (IEC 62304), including SiMD and SaMD.
Knowledge of medical electrical equipment safety (IEC 60601 series).
Familiarity with usability engineering (IEC 62366-1) and product security for medical devices.
Preferred Certifications:
Medical Device Risk Management / ISO 14971
Medical Device Design Control (21 CFR 820.30, ISO 13485, MDD/MDR)
Agile Development / Scrum Master
Six Sigma
Job Category: Research & Development / Product Design / Medical Device Engineering
Why Join Alcon:
Alcon offers a collaborative, innovative environment where associates contribute to developing next-generation medical technologies. We value diversity, equity, and inclusion, providing opportunities to grow professionally while advancing global eye care solutions.
Application Instructions:
External candidates: Apply directly through this portal.
Internal candidates or contingent workers: Apply via Alcon’s internal career site using the appropriate link.
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