Alcon - Lake Forest, CA

posted 4 months ago

Full-time - Senior
Lake Forest, CA
Miscellaneous Manufacturing

About the position

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. As Principal Engineer, Early Process Design and Development in Lake Forest, CA, the ideal candidate will be a senior member of a high performing team, specialized in the design and development of processes, fixtures, and test methods used in new product development. In this role, a typical day will include embedding as the Process Design and Development representative on R&D project teams responsible for estimating budgets and timelines for all process design and development activities on a project. You will manage and prioritize multiple projects in a dynamic fast-paced R&D environment and be self-accountable to ensure all project goals and objectives are completed per committed timelines. Collaboration with cross-functional teams is essential, as well as providing process design and development expertise on a project. You will support new product introductions at internal and external manufacturing sites as well as 3rd Party Manufacturers. Effective communication and presentation of project status/risks to Leadership and Project Leads is crucial, along with timely escalation of issues to ensure project success. Working closely with product design teams to ensure Design for Manufacturability is accounted for in new product designs is also a key responsibility. You will plan, organize, schedule, and manage process design and development activities and deliverables on projects, ensuring concurrent engineering of new processes and technologies. Researching, developing, and introducing new technologies for use in the fabrication and testing of innovative product designs will be part of your duties. You will evaluate new products for manual and automated assembly, production, or manufacturing processes, design and fabricate prototype equipment and fixtures, and investigate and integrate leading-edge automation technology in support of new products. Additionally, you will create CAD files and pertinent documents for implementation of manual, semi-automated, and automated component fabrication, assembly, and final testing. Retrofitting existing processes and equipment with updated capabilities and technology will also be required. Partnering with design engineers and/or vendors to develop solutions to complex problems by designing processes, tools/fixtures that can work with various fabrication and assembly processes and equipment is essential. You will evaluate component, subassembly, and/or assembly supplier capabilities and technologies for use in the development of new products. Utilizing Six Sigma methodologies such as DMAIC or DFSS to characterize and optimize new process designs, develop performance criteria, equipment, and/or test fixtures is expected. Risk management tools such as Fault Tree Analysis and Failure Mode and Effects Analysis will be used to understand and quantify risks for design or process trade-offs. You will create and maintain Process Flow Diagrams for manufacturing and assembly of electro-mechanical medical devices, as well as initial standard operating procedures and test methods used during development and/or for Design Verification testing. Coordinating R&D Pilot Line builds and supporting manufacturing builds as required will also be part of your role. Finally, providing coaching, mentoring, and training of team or less experienced engineers to build and strengthen the culture of the organization is a key aspect of this position.

Responsibilities

  • Embed as the Process Design and Development representative on R&D project teams responsible for estimating budgets and timelines for all process design and development activities on a project.
  • Manage and prioritize multiple projects in a dynamic fast-paced R&D environment and be self-accountable to ensure all project goals and objectives are completed per committed timelines.
  • Collaborate with cross-functional teams and provide process design and development expertise on a project.
  • Support new product introductions at internal and external manufacturing sites as well as 3rd Party Manufacturers.
  • Communicate and present project status/risks to Leadership and Project Leads, and escalate issues timely to ensure project success.
  • Work closely with product design teams to ensure Design for Manufacturability is accounted in new product designs.
  • Plan, organize, schedule, and manage process design and development activities and deliverables on projects ensuring concurrent engineering of new processes and technologies.
  • Research, develop, and introduce new technologies for use in the fabrication and testing of innovative product designs.
  • Evaluate new products for manual and automated assembly, production, or manufacturing processes.
  • Design and fabricate prototype equipment and fixtures.
  • Investigate and integrate leading-edge automation technology in support of new products.
  • Create CAD files and pertinent documents for implementation of manual, semi-automated, and automated component fabrication, assembly, and final testing.
  • Retrofit existing processes and equipment with updated capabilities and technology.
  • Partner with design engineers and/or vendors to develop solutions to complex problems by designing processes, tools/fixtures that can work with various fabrication and assembly processes and equipment.
  • Evaluate component, subassembly, and/or assembly supplier capabilities and technologies for use in the development of new products.
  • Utilize Six Sigma methodologies such as DMAIC or DFSS to characterize and optimize new process designs, develop performance criteria, equipment, and/or test fixtures.
  • Utilize risk management tools such as Fault Tree Analysis and Failure Mode and Effects Analysis to understand and quantify risks for design or process trade-offs.
  • Create and maintain Process Flow Diagrams for manufacturing and assembly of electro-mechanical medical devices.
  • Create and maintain initial standard operating procedures and test methods used during development and/or for Design Verification testing.
  • Coordinate R&D Pilot Line builds and support manufacturing builds as required.
  • Provide coaching, mentoring, and training of team or less experienced engineers to build and strengthen the culture of the organization.

Requirements

  • 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.
  • Experience using 3D CAD software e.g. ISDX, Simulate, Pro-Process, Sheet Metal, Mechanism (Creo Parametric modules a plus).
  • Experience utilizing 3D CAD software to design, develop, and document plastic, die cast, sheet metal, and machine components (familiarity performing Mold Flow Analysis or FEA Analysis a plus).
  • Practical experience with the design, development and qualification of tools, fixtures and Test Methods e.g. Manual assembly, Vision Systems, Laser Welding, Ultrasonic welding, Adhesive dispensing and curing.
  • Firm understanding of Geometric Dimension and Tolerancing (GD&T) and Tolerance stack-up Analysis.
  • Practical experience and knowledge of manufacturing processes, materials, and design requirements for: plastic, die casting, sheet metal, and machine parts.
  • Good understanding of Microsoft tools (MS Project, Excel, Power Point, and Word).
  • Experience with CeTol, and DFM Analysis software is a plus.
  • 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.
  • Able to characterize and determine process capability using statistical analysis tools to determine Cpk/Ppk, Yield, defect rates, etc.
  • 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.
  • Experience programming PLCs and Graphical User Interfaces with various platforms and languages e.g., Ladder Logic, LabView, etc. a plus.

Nice-to-haves

  • Experience with CeTol, and DFM Analysis software is a plus.
  • Experience programming PLCs and Graphical User Interfaces with various platforms and languages e.g., Ladder Logic, LabView, etc. a plus.

Benefits

  • Health insurance coverage
  • Life insurance coverage
  • Retirement benefits
  • Flexible time off
  • Relocation assistance
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