Associate I, Research & Development Process & Product Design

Responsibilities

• Prepare, coordinate, document post-production risk reviews per master schedule in support of on-shore Risk Management Leads and subject matter experts; coordinate query with stakeholders and/or data analysts; analyze and summarize post-production data.
• Update Risk Management Reports (and other risk management file deliverable) when/as needed and route for approval to risk management team.
• Update traceability matrices to link requirements to objective evidence - using applicable requirement management tools.
• Support Design Control engineers and other R&D stakeholders to query internal and external databases, analyze data and summarize results and conclusions in an email and/or a report.
• Key Requirements/Minimum Qualifications:
• Bachelor of Engineering with 3-5 year experience; or MS Engineering generalist with demonstrated interest in multiple engineering and scientific fields.
• Ability to work independently, proactively identify issues, recommend and implement solutions, and deliver quality results on schedule while managing multiple tasks and customers.
• Hands on experience of ISO 14971 (Risk Management) and ISO 13485 (or US 21 CFR 820.30) or systems engineering . Some knowledge of Product Lifecycle Management (PLM) or CAD systems.
• Good interpersonal & Communication skills to build positive departmental and inter-departmental relationships in a virtual, remote and asynchronous environment.
• Technology savviness to automate simple tasks for process improvement and cycle time reduction (e.g., data queries, data analyses, documentation)
• Knowledge on project management.
• Skills and Knowledge:
• STEAM - Applied Science, Technology, Engineering, Arts and Math
• Technical Development Methodology for Medical Devices (21 CFR 820.30, ISO 13485)
• Systems Engineering or Risk Management for Medical Device (ISO 14971)
• Regulations and Guidelines
• Excellent Technical/Scientific Writing in English in a regulated environment
• Superior verbal English communication skill (in a remote environment)
• Microsoft Office suite (i.e., Word, Excel, PowerPoint, Visio)
• Experiences
• Cross Functional collaboration - Primary
• New Product Innovation - Secondary
• Accountability - Primary
• Influencing without Authority - Primary
• Managing Crisis - Secondary
• Functional Breadth - Secondary
• Work hours: 1 PM to 10 PM IST
• Relocation assistance: Yes
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• Alcon is an Equal Opportunity Employer and takes

Benefits

Additional Information

Summary of Position: At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us? The Associate I, Research & Development Process & Product Design (Science/Tech/Engineering Path), is primarily responsible for supporting Research and Development Engineering activities, including equipment specification, procurement, installation, and validation for new product development at the Alcon Ireland site. You will also maintain Research and Development equipment, report to supervisors, and ensure project milestones are met on time and within budget while adhering to safety and environmental standards. Specifics include: - Provide hands-on technical support for product design and development processes by assisting in testing, documentation, and compliance activities, ensuring accurate documentation of test results - Follow established protocols to perform routine product evaluations, maintain laboratory equipment, and collect data to support research efforts - Assist in troubleshooting product design issues and maintain compliance with regulatory and quality standards - Develop foundational knowledge in product testing, materials analysis, and technical reporting to contribute to the overall development and validation of new products - Is a peer mentor and contributes to development of associates to innovate and deliver new products.

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