Job description 

Summary of Position:

Alcon is looking to hire Design Control PPS, Associate Engineer for R&D team. Maintain legacy products risk management files (RMF) and design history files (DHF) in support of on-shore Risk Management Leads and per Alcon master schedule to support international registrations and/or re-certifications. Support on-shore Project Management Office (PMO) Design Control engineers and Platform engineers and scientists to query, analyze, identify options, prepare and present proposals, document results and conclusions to resolve potential DHF and RMF gaps. Support audit and other compliance activities by querying, analyzing and providing requested information.

Key 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:

BS of Engineering with 2 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.

Some knowledge of ISO 14971 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, Skills and Abilities

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 – 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