Job description 

Summary of Position:

Alcon is looking to hire Associate Design Control Engineer NPD for R&D team . Support senior Design Control Engineers to complete design control deliverables on a timely basis and consistently with Alcon Quality Manual Systems, project Design Plan and in collaboration with other Core Team members. Provide tactical documentation system support to Core Teams for prompt, efficient and quality execution (do it right the first time, on time)

JOB FUNCTIONS

Essential Functions

Duties are listed in order of greatest importance.  Other responsibilities may be assigned. 

Prepare, coordinate, document risk management deliverables in support of on-shore Risk Management Leads and subject matter experts; coordinate query with stakeholders and/or data analysts; analyze and summarize applicable data.   Write Risk Management Reports (and other risk management file deliverable) when/as needed and route for approval to risk management team.   Develop traceability matrices to link requirements to objective evidence – using applicable requirement management tools (e.g. Polarion).   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.

QUALIFICATIONS

Minimum Requirement

BS of Engineering with 2 year experience; or MS Project management and analytics experience (actual vs budgeted) 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 - Intermediate
• Continuous Learning - Intermediate
• Digital and Technology Savvy - Intermediate
• Operational Excellence - Intermediate
• Breakthrough Analysis - Intermediate
• Organizational Savvy - Fundamental

Skills and Knowledge:

• STEAM – Applied Science, Technology, Engineering, Arts and Math
• Project Management experience
• Superior Excel and/or other database data analysis and visualization tools
• 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)
• Data analytic tools (e.g., Alteryx, Knime or equivalent)

Experiences

• Cross Functional collaboration - Primary
• New Product Innovation - Secondary
• Accountability - Primary
• Influencing without Authority - Primary
• Managing Crisis – Secondary
• Functional Breadth - Secondary

Licenses and Certifications

ISO 13485 Auditor Preferred

ISO 14971 Training Preferred

IEC 62366 Training Preferred

Language Skills

Fluent English; excellent verbal and written communication skills