Manufacturing Engineer - San Clemente onsite

Glaukos; San Clemente (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company in ocular-related medical products is looking for a Manufacturing Engineer I. This role requires supporting product design and process improvement while ensuring compliance with regulatory standards. The ideal candidate will have a Bachelor's in Mechanical Engineering and strong problem-solving skills, working in a cross-functional team to optimize manufacturing processes.

Qualifications

• 0–2 years of experience in a manufacturing or engineering environment.
• Experience in medical device manufacturing or regulated environments.
• Knowledge of FDA Quality System Regulations and ISO 13485.

Responsibilities

• Develop and optimize manufacturing methods to ensure product quality.
• Support new product development by integrating manufacturing considerations.
• Prepare and maintain technical documentation in compliance with GMP.

Skills

Analytical abilities

Problem-solving

Communication

Education

Bachelor’s degree in Mechanical Engineering

Tools

CAD design

Microsoft Office Suite

ERP systems

Job description

GLAUKOS – Manufacturing Engineer I (San Clemente, CA)

Job Title: Manufacturing Engineer I
Location: San Clemente, CA

How will you make an impact?

As a Manufacturing Engineer I, you will support the design, development, scale-up, and improvement of manufacturing processes for ocular-related medical products. This role involves hands-on problem-solving, process optimization, validation activities, and cross-functional collaboration to ensure high-quality, cost-effective production that complies with regulatory standards. You will contribute to the continuous improvement of systems and processes, helping ensure product performance and patient safety.

What will you do?

• Develop, optimize, and document manufacturing methods and processes to ensure efficiency, cost-effectiveness, and high product quality.
• Support both new product development and modifications of existing products by integrating manufacturing considerations into product design.
• Provide day-to-day engineering support to production teams, including addressing and resolving manufacturing issues to improve yield and reduce cost.
• Identify opportunities for process improvements and cost savings; conduct analyses and make data-driven recommendations.
• Prepare and maintain technical documentation including protocols, reports, procedures, FMEAs, and work instructions in compliance with GMP and internal standards.
• Collaborate with internal teams and external vendors to specify and design tools, fixtures, and manufacturing equipment.
• Assist with equipment qualification and process validation; apply appropriate methodologies such as Six Sigma and Design of Experiments (DOE).
• Utilize ERP systems to support manufacturing activities and maintain accurate records.

How will you get there?

• Bachelor’s degree in Mechanical Engineering or a related engineering discipline.
• 0–2 years of experience in a manufacturing or engineering environment.
• Strong analytical and problem-solving abilities.
• Effective verbal and written communication skills.
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Experience in CAD design (2D/3D) for tools and fixtures.
• Ability to work effectively in cross-functional teams and meet project timelines.
• Experience in medical device manufacturing or a regulated industry.
• Familiarity with FDA Quality System Regulations (21 CFR 820) and ISO 13485 standards.
• Exposure to cleanroom environments and precision assembly under a microscope.
• Experience with ERP systems and project scheduling tools (e.g., MS Project).
• Working knowledge of process validation, Six Sigma, and cGMP practices.
• Ability to contribute to multiple phases of product development, from concept to production release.

Work Environment & Physical Requirements

• May require work in cleanroom and laboratory settings.
• May involve the use of microscopes and fine assembly tools.
• Occasional lifting of materials or equipment may be required.

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