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Scientific. Clinical. Software Engineering

Sr. Opto Mechanical Engineer

Orange County Metro Area, CA

Job Type: Engineering Job Number: JN -022020-26451 Region: Orange County Metro Area

Job Description

Sr. Opto Mechanical Engineer

Biotech Industry

Irvine, CA


Duties:


Competencies Include:

o Ability to break down complex problems into component parts.

o Identify and Understand underlying issues.

o Develop quantitative analysis.

o Make decisions without hesitation.

o Anticipate the long-term needs, opportunities, and threats to a project; take appropriate action.

o Build support for ideas.


Design systems incorporating some or all of the following:

o High precision motorized mechanisms

o Lens and mirror mounts large and small

o Flexures and kinematic mounts

o Metal castings, plastic moldings, additive manufacturing

o Design for Manufacture


Define, develop, and fabricate new solutions to ensure optimal design approach and required product performance during prototype development, as well as transition to volume production. Includes mechanical design principals to create tools and automated manufacturing solutions.

Design, assembly, alignment, measurement, testing, analysis, and troubleshooting of optical, illumination, fiber optic, and laser delivery devices.

Define (or develop) new compensation and optical performance tests to validate completed assemblies.

Provide advanced analysis and characterization of optical systems, including customized performance simulations, in order to demonstrate compliance with detailed specifications.

Lead, participate in, or support medical device development activities such as prototyping and testing, pilot builds, V&V, and risk assessment.

Support tests and analysis of prototype units and mockups. Characterize solutions for optical stability, repeatability, and reliability through experiments and structured test plans.

Prepare product and component documentation, such as requirements, specifications, reports, design/assembly drawings.

Support all aspects of documentation and design control through ECN, ECO, and Windchill

Responsible for improving costs, quality, and design of existing products

Troubleshoot technical opto-mechanical production problems and support product repair activities.

Resolve quality and customer support issues by lending expertise to respective departments

Build and maintain professional, constructive working relationships with other departments and with suppliers

Work safely as well as identify and report any safety hazards immediately


Skills:


Proficient with SolidWorks and or Creo solid modelling mechanical design software.

Experience with industry standard tools & methods for optical, photonic, & electro-optical systems engineering

Rapid prototyping capabilities and proficiency, including but not limited to 3D printing, CNC machining, sourcing of standard components, improvisation, and etc.

Excellent written and oral communication skills.

Demonstrate prior success in fast-paced, complex working environments.

Must possess the following soft skills : Acts with Integrity, Attention to Detail, Clear Communicator, Goal Setting / Drives for Solutions, Prioritization/Multi-task, Problem Solver/Decision Maker, Self-Motivated, Team Player.


Education:

Minimum requirements


Bachelor s Degree in Mechanical Engineering, Optics, Physics, or related field+ 5 Years of Relevant Experience, or equivalent years of directly related experience (Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)


Preferred Qualifications


Graduate degree in Mechanical Engineering, Optics, Physics, or related field

Experience with software tools to automate optical design and analysis tasks (e.g., CODE V and ZEMAX macro languages)

Applied Knowledge of Materials engineering or material science related to optical materials & polymers

Highly motivated individual with a proven track record (15+ years) in opto-mechanical design and product development

Possess expert level knowledge of trade-off and margin analysis between optical performance and mechanical design, mechanical tolerance, optical design and optical tolerances.

Possess expert level experience in integration of design through external supply chain and fabrication techniques in-house.

Must drive design and execution through realization in the manufacturing environment on accelerated high profile project.

Must drive through release all design and manufacturing documentation.

Enjoys hands-on work. It is routine to participate in build and test of your designs

Class II & III medical device experience

Biomedical product or medical device development experience

Knowledge of fabrication and manufacturing optical systems is highly desirable.

Design Controls - 21 CFR 820/ISO 13485

Risk Management proficiency - ISO 14971

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