Sr. Device Design Engineer

Responsibilities

• Responsible for supporting device engineering activities for ocular health related new products. He/she will support research & development in the area of novel ophthalmic devices (including novel packaging/ delivery devices)
• Hands on participation in or support the product development activities such as design development, prototyping/testing, pilot builds, verification & validation testing, risk assessment and production tooling validation.
• Applies statistical principles to communicate meaningful conclusions relevant to customer needs
• Applies knowledge of materials and manufacturing methods for medical devices
• Generate detailed fabrication drawings utilizing GD&T and tolerance analysis, appropriate product requirements and technical file documents and lead design reviews.
• Applies principles of engineering analysis to blend technical knowledge and manufacturing practices in providing solutions to complex engineering challenges.
• Develops requirements, leads design reviews, performance of verification and validation, production transfer and related documentation.
• Generates internal reports for communication with cross-functional members and management.
• Support all aspects of documentation. Verification Plans and Reports; and design control through ECN, and Windchill.
• Support existing device and ophthalmic packaging by addressing select product support requests and addressing questions on existing products.
• Ensures regulatory / statutory / legislative compliance for all project work.

Key Requirements/Minimum Qualifications:

• Bachelor's Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+1 yr)
• The ability to fluently read, write, understand and communicate in English
• 5 Years of Relevant Experience
• 3 Years of Demonstrated Leadership
• Travel Requirements: No
• Relocation assistance: Yes
• Sponsorship available: Yes

Preferred Qualifications:

• Experience in medical device is preferred.
• Proficiency in CAD. SolidWorks or Creo preferred.
• Working Knowledge with FEA analysis is preferred
• Proficiency with statistical analysis and software is preferred
• Experience with evaluation of mechanical systems and assemblies.
• Working knowledge and experience with fluidic systems.
• Working knowledge and experience with electronics and electrical systems.
• Ability to perform root cause analysis investigation
• Knowledge of ISO, FDA, MDD and regulations applicable to the design and development of medical device/science/technology.
• Excellent technical writing capability in generating technical documentation and scientific papers.
• Working knowledge of Solid Works/ PTC Creo and related detailed drawings.
• Working knowledge and experience with mechanical systems and assemblies.
• Ability to work under minimum oversight to identify and prioritize work activities as necessary to achieve project goals within set timelines.
• Work efficiently and productively with other team members and external partners.
• Adheres to Alcon's guidelines for appropriate workplace behaviors and attitudes.

Key Performance Indicators

Demonstrates ability to work under little direction toward predetermined goals. Courses of action that are pursued achieve minimization of life cycle costs and meet project schedule according to customer need (time, cost, functionality, and quality). Technical assistance is provided as needed to support regulatory, manufacturing, quality, marketing, and other Core Team needs. Effectively interacts with others to facilitate product development and support. Demonstrates leadership qualities. Documentation is complete, accurate and 100% compliant to regulatory and mandatory industry performance standards. Contributes ideas and/or potential innovations which would impact the R&D pipeline and provide a return on investment.

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 [email protected] and let us know the nature of your request and your contact information.