Job Description

Position Overview:

Provides technical support to R&D Engineers including process development activities, documentation efforts such as manufacturing process instructions and equipment forms, catheter assembly, prototyping, and testing as it relates to fiber optic processes. Assists engineers in new product development in all aspects of designs, manufacturability, and quality. Flexibility to adapt to sudden changes in different kinds of work schedules and tasks.

Responsibilities:

• Performs general catheter assembly using laboratory equipment, tools and microscopes.
• Perform process development activities supporting both current and new products. Processes include fiber optic cleaving, splicing, tapering, splitter and coupler assembly, ferrule / connector assembly, sensor assembly, and end face inspection / cleaning.
• Build prototypes devices and test samples in accordance with engineering instructions, or drawings and specifications. Provides inputs to engineers as necessary.
• Participate in the design and development of new concepts.
• Assists with development of manufacturing processes and corresponding transfer to production.
• Supports Engineering with root cause analysis and discovering then implementing process improvements.
• Sets up and operates manufacturing and/or test equipment, and records data with limited supervision.
• Gathers, maintains, formats, compiles, and manipulates technical data, such as laboratory or material test results and engineering design changes.
• Partners with engineering staff on project needs.
• Supports R&D in device testing to inform design and/or process updates.

Qualifications:

Education:

• A minimum of High school or equivalent education.

Required Experience:

• 6+ months experience in medical device industry.
• 2+ years experience in fiber optic assembly.
• Hands-on experience in medical device manufacturing and production
• environment or prototyping experience.
• Working knowledge of catheters and microscopes in medical device laboratory.
• Working knowledge of word processing and spreadsheet software.

Preferred Experience:

• Ability to quickly interpret and comprehend engineering drawings and specifications.
• Use of measurement devices and required safety equipment when performing lab work.

1. Knowledge, Skills, and Abilities:

• The candidate should have good organizational skills, personal skills, and a strong follow-through “can do” attitude.
• Monitors own work to ensure quality.
• Must also verbally communicate work to engineers and other staff in a clearly understood, organized and logical manner.
• Familiar with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and laboratory practices.

Knowledge, Skills, and Abilities:

• The candidate should have good organizational skills, personal skills, and a strong follow-through “can do” attitude.
• Monitors own work to ensure quality.
• Must also verbally communicate work to engineers and other staff in a clearly understood, organized and logical manner.

Familiar with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and laboratory practices.

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