Sr. Associate I – R&D Process & Product Design (T)
Location: Bangalore, India
Job Type: Full-Time
Experience Required: 5–7 years in medical device product development
Application Deadline: February 27, 2026
About the Role
Alcon is seeking a highly skilled Sr. Associate Engineer to join our Research & Development team in Bangalore. This role will focus on applying Design Control and Risk Management principles to software and medical device development, including Software in a Medical Device (SiMD), Software as a Medical Device (SaMD), and supporting non-clinical software applications.
As a Sr. Associate, you will act as a Subject Matter Expert (SME) in design control and risk management, driving compliance with global regulations, guiding teams, and ensuring high-quality product development across Alcon’s ecosystem of instruments and software solutions.
Key Responsibilities
Develop and maintain Design History Files (DHFs) and Risk Management Files (RMFs) to support efficient global product registrations and launches, minimizing regulatory queries, audit findings, and CAPAs.
Serve as SME on design control and risk management standards, including FDA 21 CFR 820.30, ISO 13485, ISO 14971, IEC 62304, IEC 60601, MDD/MDR, MDCG guidance, and Alcon Quality System requirements.
Lead Design Phase Reviews and guide teams in assembling review materials that document compliance with design plans and regulatory expectations.
Implement systematic requirement management, ensuring traceability from design inputs to outputs, verification, validation, and risk mitigation.
Lead risk management activities, including planning, hazard identification, FMEA, FTA, Task Analysis, benefit-risk analysis, usability, product security, and residual risk disclosure.
Coach and mentor project teams on effective application of design control, risk management, usability, software development, and product security processes.
Champion best practices, ensuring knowledge transfer and consistency across projects and teams.
Required Qualifications and Skills
Experience: 5–7 years in medical device product development, covering electrical, mechanical, optical, or software domains.
Strong expertise in Design Control for medical devices (21 CFR 820.30, ISO 13485, MDD/MDR).
Proven experience in Risk Management (ISO 14971) for medical devices.
Knowledge of software development standards for medical devices (IEC 62304), including SiMD and SaMD.
Understanding of medical electrical equipment safety (IEC 60601 series).
Familiarity with Usability Engineering (IEC 62366-1) and Product Security principles.
Excellent communication, collaboration, and mentoring skills.
Strong organizational skills with ability to manage multiple deliverables in cross-functional teams.
Preferred Certifications
ISO 14971 – Medical Device Risk Management
21 CFR 820.30 / ISO 13485 – Design Control for Medical Devices
Agile Development / Scrum Master
Six Sigma
Why Join Alcon
Be part of a global leader in eye care and medical device innovation.
Work on cutting-edge R&D projects with impact on millions of patients worldwide.
Collaborate with cross-functional, highly skilled teams in a dynamic, growth-focused environment.
Contribute to regulatory compliance and innovation in medical device design and software development.
Alcon is committed to fostering diversity, equity, and inclusion, and is an Equal Opportunity Employer. All qualified candidates will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other legally protected characteristic.
Application Note:
If you are a current Alcon employee or contingent worker, please apply via the internal career portal.
This version is:
SEO optimized: keywords like “Medical Device Design Control,” “Risk Management ISO 14971,” “SiMD SaMD,” “R&D Engineer Bangalore”.
GEO optimized: Location Bangalore clearly highlighted.
Experience highlighted: 5–7 years in medical device R&D prominently mentioned.
Written in a professional tone, structured for clarity, and GPT-friendly for candidate engagement.a
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