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Alcon · 1 month ago

Principal Opto-Mechanical Engineer II

Lake Forest, CA

Full-time

Onsite

Lead/Staff

10+ years exp

Alcon is a company dedicated to enhancing sight and improving global eye health. The Principal Opto-Mechanical Engineer II will lead teams in designing, validating, and optimizing optical components and systems, while ensuring high-precision designs and compliance with regulatory requirements.

Health CareManufacturingMedical Device

No H1B

Responsibilities

Oversee multiple optical engineering projects, leading teams in the design, validation, and optimization of optical components and systems

Conduct advanced research on light behavior, material properties, and optical performance

Ensure designs meet high-precision and regulatory requirements

Apply deep expertise in optical modeling and decision-making on system architectures

Collaborate cross-functionally to develop cutting-edge optical solutions

Adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training

Commit to continuous improvement and contribute to the overall compliance of the organization

Apply in-depth knowledge of Opto-Mechanical Engineering in Ophthalmic related Diagnostic & Visualization surgical instrumentation domain as SME across a range of engineering disciplines including, Mechanical Design, Opto-mechanics, Optics, Fiber Optics, Material Science, Precision Machining, Imaging, Illumination, Microscope and Optical Systems Design

Perform Opto-mechanical design including lens barrel and lens housing design, lens bonding and mounting techniques, and opto-mechanical analysis including thermal, environmental, shock & vibration, system integration and stability tolerance study

Conduct design, research, development, and process upscaling for new medical device products

Investigate and evaluate existing technology and designs new methodology, materials, machines, or processes as needed for Ophthalmic medical device development. Design, assembly, alignment, measurement, testing, analysis, and troubleshooting of diagnostics and visualization devices

Understand operation principles for optomechanical and electromechanical actuators and sensors and integrate these within complex sub-systems

Generate detailed parts fabrication drawings including GD&T and tolerance analysis

Support medical device development activities such as prototyping, testing, pilot builds, V&V, risk assessment, and ramp-up to production release

Support all aspects of documentation and design control through PECN, ECN, ECP in Product Lifecycle Management (PLM) platform (Windchill preferred)

Develop assembling and alignment fixtures for prototype fabrication and create associated manufacturing assembling (MAP) and manufacturing testing processes (MTP)

Support concurrent engineering activities, design control and transition to manufacturing

Technical lead for feasibility study and new product development ensuring that design activities are conducted following Alcon SOPs

Derive product design requirements based on top-level commercial input

Identify technical, project schedule, and commercial viability risks

Run cross-functional design trade-off and technical reviews to drive design decisions

Work effectively with cross-functional development teams including Optics, Mechanical, Electrical, Software, QA, Industrial Design and Manufacturing functions

Team player/collaboration aptitude with strong sense of accountability and perseverance to lead and drive projects through to completion

Make contributions to ideations, patent portfolio and the corporation strategy development

Qualification

Opto-Mechanical EngineeringOptical System DesignOptical ModelingImaging System DevelopmentCREO (Pro-E)SolidWorksOptical Design ToolsFailure Mode Effects AnalysisBiomedical Product DevelopmentTeam CollaborationProject ManagementCommunication Skills

Required

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

Proficiency in CREO (Pro-E), SolidWorks, or Equivalent CAD skills (CREO preferred) in PLM or Windchill environment

Strong background with design and development of Imaging system such as Microscope, Eyepiece, telescope, zoom lens as well as ophthalmic related Diagnostic & Visualization devices

Proficiency in opto-mechanical system design, optical alignment technology, tolerance analysis, material selection, design for athermalization, bonding and assembly processes

Experienced with FEA tool such as ANSYS, and familiar with MATLAB, LabView

Knowledge of optical design tool such as ZEMAX, Code V, and familiar with optical/mechanical design integrating process

In-depth ophthalmic domain knowledge (Cataract, Vit-Ret, Refractive Surgery, or Diagnostics)

Solid understanding of Design Controls according to 21 CFR 820 or ISO 13485

Proficient in Failure Mode Effects Analysis and Risk Management application to medical devices

Industry standard tools and methods for optical, mechanical and optomechanical engineering are essential

Domain knowledge in Optics, Opto-mechanics, Fiber Optics, Imaging, Illumination and Visualization

Optical and Optomechanical metrology and testing practices

Broad knowledge of precision manufacturing techniques and familiarity with assembly of micro-optical and miniature optomechanical components

Understanding of architecture design, requirements and risk management, medical device V&V, reusable, and single-use consumable medical devices

Biomedical product or medical device development experience

Vendor and supplier management for optical components, complex sub-systems, or OEM