Principal Process Engineer

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 Principal Process Engineer in Irvine, CA, this person:

• Conducts process research, process development and process upscaling for new medical device products.

• Investigates and evaluates existing technology and designs new methodology, materials, machines or processes as needed for medical device development. Plans, conducts and provides technical direction to one or more projects of major importance and difficulty where the complexity of technical problems involved requires the broad application of advanced knowledge of ophthalmic devices.

• Interprets complex study results or may manage programs or provide other engineering leadership.

In this role, a typical day will include:

• Provides authoritative technical or professional advice and recommendations to influence internal and/or external contacts.

• Internal and external audience is diverse and interaction mainly requires interpretation of complex information.

• Audience may be outside own area and unfamiliar with subject.

• Designs major components, or major portions of a functional system, or technically advanced prototype, or specific products 

• for medical device/science/technology.

• Uses intermediate level analytical techniques and/or previous experience to identify the most appropriate option or to adapt or improve existing approaches.

• Applies intermediate level engineering principles to the research and development of medical device/science/technology and/or provide engineering expertise to support development.

• Assures continuity of products and processes assessment feasibility, research, design, development, compliance to customer and non-customer requirements, transfer to production.

• Provides engineering direction, determining and developing approach to solutions by coordinating multiple resources to solve complex problems.

• Leads design reviews, assigns and reviews action items.

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

• Acts as a mentor in the engineering organization.

• Has autonomy to propose alternatives but normally follows a specified course of action.

• Decisions impact short term.

• Requires awareness of the workings of the business beyond own team and some familiarity with the external environment as it affects own part of the organization.

Skills/Experience:

• Experience working in a Medical Device environment and familiar with medical device regulations and standards e.g., QSR 21 CFR 820, ISO 13485

• Exceptional communication and interpersonal skills, with the ability to work effectively at all levels of the organization and experience with conflict resolution

• Excellent project management skills and experience leading cross-functional teams

• Strong analytical, problem-solving, and decision-making capabilities

• Six Sigma Certification Green Belt Certification preferred (Black Belt Certification a plus)

• Practical experience with process qualification/validations e.g., IQ/OQ/PQ, Gage R&R

• Proficient in performing Statistical analysis e.g., hypothesis testing, regression testing and use of DOEs for process characterization and optimization (experience using statistical tools e.g. MiniTab a plus)

• Must be able to author engineering studies, protocols and reports

What You'll Bring to Alcon:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs) 

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

• 5 Years of Relevant Experience

How You Can Thrive at Alcon:

• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!

• Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more!

• Travel Requirements: 0-5%

• Relocation assistance: Yes

• Sponsorship available: No

Alc