Description
Position Summary:
Our client, a leader in precision optical and electro-mechanical manufacturing, is seeking an experienced Manufacturing Engineer (Contract) to support the development, optimization, and validation of manufacturing processes for complex components and assemblies. This role offers the opportunity to apply hands-on technical expertise in a regulated environment, with preferred experience in medical devices, cameras, fiber optics, or endoscopic systems. Candidates from aerospace manufacturing backgrounds are also encouraged to apply.
Key Responsibilities:
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Lead the design, development, and optimization of manufacturing processes, tools, and procedures for optical and electro-mechanical assemblies.
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Drive continuous improvement initiatives to enhance yield, efficiency, and product quality through root cause analysis and structured problem-solving.
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Collaborate cross-functionally with engineering, quality, and production teams to ensure compliance with product requirements and regulatory standards.
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Develop and maintain process documentation and validation packages in accordance with FDA and ISO 13485 standards.
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Support the transition from prototype to full-scale production while maintaining product integrity and performance.
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Evaluate, specify, and implement new production equipment and tooling as needed.
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Provide hands-on technical support for troubleshooting and production issues.
Qualifications:
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Education: BS/MS in Manufacturing Engineering, Mechanical Engineering, Optical Engineering, or related field.
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Experience: 5–10+ years in manufacturing engineering, preferably within a regulated (FDA, ISO 13485, or aerospace) environment.
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Proven experience introducing new processes and equipment into production, including process validation and documentation.
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Strong understanding of machining processes, assembly methods, and precision optical/mechanical manufacturing.
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Experience with optics fabrication, fiber optics, or imaging systems is a plus.
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Proficient in process validation, statistical analysis, and risk management.
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Excellent communication and project management skills, with the ability to manage multiple priorities in a fast-paced environment.
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Experience collaborating with cross-functional teams and external vendors.
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U.S. citizenship or permanent residency may be required for certain projects.
Preferred Skills:
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Hands-on experience in medical device manufacturing, particularly in optical imaging or endoscopic systems.
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Familiarity with cleanroom assembly and electro-optical system integration.
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Knowledge of Lean Manufacturing, Six Sigma, or continuous improvement methodologies.
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Experience with CAD, SolidWorks, or optical modeling software (e.g., Zemax, Code V).