System and Analytics Associate Engineer

Summary of the Position:

• Support Alcon New Product Development projects with deep understanding of environmental regulations related to materials used in ophthalmic medical devices and pharmaceutical eye care products.

  
  

• Demonstrate compliance of new products to environmental regulations

  
  

• Collaborate with cross-functional teams (e.g. R&D, manufacturing, regulatory, quality) to ensure compliance with environmental regulations.

  
  

• Provide custom queries and analyses to new product development teams.

  
  

• Make or influence use of technology to automate query and analysis process for time and resource efficiencies

  
  

• Schedule, budget, track and analyze post-production R&D activities in support of registration and/or recertification and compliance schedule (i.e., MDR periodic deliverables to maintain CE Mark and change control)

  
  

Major Accountabilities

• Assesses compliance of materials used in Alcon new product development by providing pass/fail decisions to design team as soon as possible.

  
  

• Maintains databases of requirements and risks, and their traceability matrix using Alcon Application Lifecycle Management (ALM) system, and demonstrates safety, performance and compliance to latest standards.

  
  

• Maintains design history files (DHF) using Alcon Product Lifecycle Management (PLM) systems.

  
  

• Queries internal and external databases, analyzes data and summarizes results and conclusions in a tracker, an email and/or a report. 

  
  

• Supports Design Control engineers and other R&D stakeholders by creating data visualization and providing data update from various assessments.

  
  

• Internal interaction may require interpretation of complex information and external interaction may require exchange of factual information. Audience may be outside own area and unfamiliar with subject.

  
  

• Applies intermediate level principles of engineering analysis, blend technical knowledge and manufacturing practices in providing solutions to problems arising within the department pertaining to the assigned projects.

  
  

• Uses previous experience to identify the most appropriate option to adapt or improve existing approaches.

  
  

• Interprets information to make decisions impacting own scope of work. 

  
  

• Ensures regulatory / statutory / legislative compliance for all project work.

  
  

• Operates within clear guidelines with regard to how to handle decisions outside direct experience. Issues arising outside guidelines or operating procedures are normally escalated for resolution.

  
  

Key Performance Indicators

• Demonstrates ability to work with some direction toward predetermined short-range goals.

  
  

• Assignments are occasionally self-initiated.

  
  

• Follows established procedures with some supervision to achieve minimization of life cycle costs and meet project schedule according to customer need (time, cost, functionality and quality).

  
  

• Encounters problems that are varied but similar; requires some fact-finding to define problem. Selects the best option from a set of defined procedures or based on precedence.

  
  

• Technical assistance is provided as needed to support regulatory, manufacturing, quality, marketing and other needs.

  
  

• Effectively interacts with others to facilitate product development and product lifecycle management and support.

  
  

• Documentation is complete, accurate and 100% compliant to regulatory and mandatory industry performance standards.

  
  

• Communicates factual, sometimes complex, information to internal and/or external contacts.

  
  

• Internal and external interaction requires exchange of factual information.

  
  

• Requires awareness of impact of interaction with fellow team members and other contacts.

  
  

• May contribute ideas which would impact the R&D pipeline, lifecycle products, and provide a return on investment.

  
  

Impact on Organization

Erroneous decisions or recommendations would normally result in serious program delays and considerable expenditures of resources.

Competency Profiles

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

• Technical Development Methodology for Medical Devices and Pharmaceutical Products

  
  

• Superior Excel and/or other database analysis and visualization tools

  
  

• STEAM – Applied Science, Technology, Engineering, Arts and Math

  
  

• Regulations and Guidelines

  
  

• Excellent Technical Scientific Writing in English in a regulated environment

  
  

• Project Management

  
  

• Product Lifecycle Management (PLM) applications

  
  

• Application Lifecycle Management (ALM) applications

  
  

Experiences

• Cross Functional collaboration - Primary

  
  

• Accountability - Primary

  
  

• Influencing without Authority - Primary

  
  

• Managing Crisis – Secondary

  
  

• Functional Breadth - Secondary

  
  

• New Product Innovation - Secondary

  
  

Education

BS in Materials Science, Materials Engineering, or Chemical Engineering with 3 year experience; or MS with 1 yr experience in the Medical Device industry or pharmaceutical industry

Experience

• Strong knowledge of relevant environmental regulations, including REACH, RoHS, Proposition 65, CLP, BPR, POPs.

  
  

• Strong verbal and written communication.

  
  

• Proficiency in distilling complex concepts into clear and concise presentations for diverse audience, including leadership.

  
  

• Detail-oriented with the ability to manage multiple projects simultaneously.

  
  

• Basic project management and analytics experience (actual vs budgeted)

  
  

• Technology savviness to automate simple tasks for process improvement and cycle time reduction (e.g., data queries, data analyses, documentation)

  
  

• Proven ability to develop solutions for problems that require the regular use of creativity.

  
  

• Interacts with senior professionals on difficult matters.

  
  

• Knowledge of ISO, FDA, MDR and regulations applicable to the design and development of medical device/science/technology.

  
  

• Excellent process management and problem solving skills.

  
  

• Understands applied practice, concepts and processes in a defined discipline or scientific/technical field.

  
  

• Provides specific advice in own area and recommends improvements to well established and clearly defined processes.

  
  

• Encounters problems that are varied but similar. Requires some fact-finding to define problem. Selects the best option from a set of defined procedures or based on precedence.

  
  

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