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Sr. Engineer I

3 months ago

Fort Worth, United States Alcon Full time

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Sr. Engineer I, Design Control Systems and Analytics in Fort Worth, TX, you will have the following duties.

  • 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)

  • Mentor junior engineers

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.

Additional Experience:

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

  • 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.

Key Requirements/Minimum Qualifications:

  • Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs) 

  • The ability to fluently read, write, understand, and communicate in English

  • 2 Years of Relevant Experience 

  • Work hours: M-F, standard

  • Travel Requirements: 0-5%

  • Relocation assistance: yes

  • Sponsorship available: no    

#LI-DNI

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to 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 or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.