Associate II, Software Engineering

Alcon; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Alcon is seeking a documentation specialist to plan and coordinate software documentation changes, ensuring updates are captured in the DHF and repository. You will collaborate with on-shore and off-shore teams, support audits, regulatory activities, and align with the Lake Forest development team.

Responsibilities include coordinating post-production deliverables, maintaining electronic DHF/TFS, and ensuring compliance with release procedures for post-market changes, while communicating

Qualifications

• Bachelor’s in Computer Science or related discipline with 2 years of experience, or 5 years relevant experience.
• Ability to work independently and deliver on schedule while handling multiple tasks.
• Knowledge of ISO 14971 and ISO 13485 or US 21 CFR 820.30; systems engineering.
• Preferred knowledge of IEC 62304.
• Knowledge of SDLC (Software Development Lifecycle).
• Strong written and verbal English in a regulated environment.
• Experience with document management systems (PLM Windchill preferred).
• Experience with Visual Studio, Azure DevOps or other IDEs.
• Intermediate Microsoft Word skills (TOC, tables, and macros).

Responsibilities

• Plan, coordinate, and document post-production software deliverable updates per the master schedule.
• Submit and monitor approval cycles for required deliverables.
• Maintain electronic DHF and TFS repositories for documentation.
• Assure compliance with software release procedures for post-market changes.
• Support audit, regulatory activities by providing requested information.
• Collaborate with Lake Forest software development team to support deliverables.

Skills

Independent work

Communication skills

Cross-functional collaboration

Influencing without authority

Problem solving

Written English

Education

Bachelor’s in Computer Science or related discipline

Tools

Visual Studio

Azure DevOps

Windchill

Microsoft Word

MS Excel

Visio

Job description

Summary of Position

Plan and coordinate software documentation changes per procedure, and in partnership with stakeholders. Assure updates are included in the designated document repository and the appropriate DHF. Collaborate with on-shore and off-shore Software Verification and Validation teams to supply inputs for test cycles and documentation updates after testing. Support audit, regulatory, and other compliance activities by querying, analyzing, and providing requested information. Update documentation as required for changes in regulatory requirements. Work closely with the Lake Forest software development team to support software development activities and associated deliverables.

Key Responsibilities

• Prepare, coordinate, and document post-production software deliverable updates per the master schedule in support of Software Development leads.
• Submit and monitor approval cycles for required deliverables.
• Maintain electronic software DHF and TFS repositories for documentation.
• Assure compliance with software release procedures for post-market changes.

Key Requirements / Minimum Qualifications

• Bachelor’s in Computer Science, Software Development, MIS, BIS, or another related discipline with 2 years of experience; or 5 years of relevant experience.
• Ability to work independently, proactively identify issues, recommend and implement solutions, and deliver quality results on schedule while managing multiple tasks and internal customers.
• Some knowledge of ISO 14971 and ISO 13485 (or US 21 CFR 820.30) or systems engineering.
• Preferred knowledge of IEC 62304.
• Some knowledge of Software Development Lifecycle Management (SDLC).
• Good interpersonal and communication skills to build positive departmental and inter-departmental relationships in a virtual, remote, and asynchronous environment.
• Experience with document management systems (preferred: PLM Windchill).
• Experience with Microsoft Visual Studio, Azure DevOps (ADO), or other integrated development environment (IDE) tools.
• Intermediate Microsoft Word skills, including TOC, tables, and macros.

Knowledge, Skills, and Ability

• Personal Effectiveness Competencies Project Excellence – Fundamental
• Continuous Learning – Intermediate
• Digital and Technology Savvy – Intermediate
• Operational Excellence – Intermediate
• Breakthrough Analysis – Intermediate
• Organizational Savvy – Intermediate
• Skills and Knowledge STEAM (Science, Technology, Engineering, Arts, and Mathematics)
• Technical Development Methodology for Medical Devices (21 CFR 820.30, ISO 13485)
• Systems Engineering or Risk Management for Medical Devices (ISO 14971)
• Medical Device Software Life Cycle Processes (IEC 62304)
• Regulations and Guidelines
• Excellent technical/scientific writing in English in a regulated environment
• Superior verbal English communication skills in a remote environment
• Microsoft Office Suite (Word, Excel, PowerPoint, Visio)
• Experience Cross-Functional Collaboration – Primary
• New Product Innovation – Secondary
• Accountability – Primary
• Influencing Without Authority – Primary
• Managing Crisis – Secondary
• Functional Breadth – Secondary
• Licenses and Certifications (Preferred) Medical Device Risk Management – ISO 14971
• Medical Device Design Control – US 21 CFR 820.30
• Medical Device Software LCM – IEC 62304 (listed as IEC 62034 in the document, likely a typographical error)

Work Hours

1 PM to 10 PM IST

Relocation Assistance

Yes

Equal Opportunity Employer Statement

Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.

About Alcon

At Alcon, we are committed to helping people see better. We believe patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well-known Opti-Free line of contact lens solutions and related products. Alcon, which was founded in 1945, sells its products in 180 countries worldwide.