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RxSight, Inc. · 1 day ago

Manufacturing Engineer II

Aliso Viejo, CA

Full-time

Onsite

Mid Level

$80K/yr - $100K/yr

3+ years exp

RxSight, Inc. is an ophthalmic medical technology corporation that has commercialized the world's first adjustable intraocular lens. The Manufacturing Engineer II will support continuous improvement and maintain robust manufacturing processes, collaborating with Design Engineering and Quality Control to ensure production line sustainability and compliance with regulations.

BiotechnologyEyewearHealth CareMedical Device

H1B Sponsor Likely

Responsibilities

Lead effort in support of continuous improvement initiatives aimed at enhancing production efficiency, ensuring business continuity, and maintaining regulatory compliance

Provide troubleshooting expertise for equipment-related issues and offer technical support to operators and technicians as required

Establish and execute validation strategies (IQ/OQ/PQ) for new processes, and equipment in compliance with ISO 13485 and FDA regulations

Initiate documents such as drawings, work instructions, and reports ensuring proper routing through the quality management system

Perform training necessary for the implementation of processes/tooling changes as necessary

Set up, operate, and maintain various manufacturing equipment and tools

Perform diagnostics, troubleshoot, and repair complex electrical, mechanical, network and software issues

Participate in root cause analysis and implement corrective actions for manufacturing issues

Ability to stay on tasks with minimal supervision and minimal direction

Qualification

Continuous improvementISO 13485 complianceLean manufacturingSolidWorks PDMElectrical troubleshootingMechanical troubleshootingManufacturing practicesProject Management SystemInterpersonal skillsOrganizational skillsClear communicationSelf-motivated

Required

Bachelor's degree in Biomedical, Electrical, or Mechanical Engineering with a minimum of 3 years of technical experience

Master's degree in Biomedical, Electrical, or Mechanical Engineering with a minimum of 2 years of technical experience

Continuous improvement experience

Familiarity with regulatory standards (ISO 13485)

Familiarity with good manufacturing practices (GMP) and good documentation practices (GDP)

Demonstrates a hands-on approach to problem solving, ensuring prompt task closure

Proficient in conducting training sessions and initiating engineering change requests

Professional, responsible, energetic, and accountable

Strong interpersonal skills – the ability to communicate effectively at multiple organizational levels including technicians, Engineering, Chemistry, and Production operators

Clear communicator – understands how to distill information to have substantive discussions with the right audience

Strong Organizational skills – the ability to balance and prioritize multiple studies, and manufacturing builds

Continued appetite to learn about our technology, its performance characteristics, and its manufacturing process – our process and our technology are unique

Self-motivated, proactive, and able to work effectively under minimal supervision