Medical Device Assembler - 1st Shift

Job Title:

Cleanroom Assembler – Medical Device (Entry Level and Experienced) Job Description

This role focuses on assembling highly precise medical devices, including catheters used in the brain to help prevent aneurysms. You will work primarily under a microscope in a cleanroom or lab environment, using small hand tools to assemble very small components. The position offers structured training for entry‑level candidates, growth into R&D and line support roles, and the opportunity to transition into a full‑time permanent role with comprehensive benefits.

• Assemble small and delicate medical device components, including coiling wire and small tubing, according to detailed work instructions and quality standards.
• Work under a microscope for extended periods to perform precise and accurate assembly tasks.
• Use small hand tools and equipment safely and effectively to build and handle tiny parts.
• Support cleanroom production activities by following strict cleanliness, gowning, and contamination control procedures.
• For R&D assemblers, build products in a pilot line lab environment and eventually in a controlled CER environment.
• For R&D assemblers, perform specialized tasks such as working with coils, hot boxes, iron soldering, UV bonding, and using measuring equipment including rulers, VIS, snap gauges, calipers, and micrometers.
• For line assistants, perform Good Documentation Practice (GDP) reviews to ensure all production and quality records are complete and accurate.
• For line assistants, work within an ERP system to open and close work orders and issue materials to those work orders.
• For line assistants, perform cycle counts and verify inventory accuracy in the cleanroom environment.
• Follow all safety, quality, and regulatory guidelines related to medical device manufacturing.
• Maintain consistent attendance, demonstrate strong work ethic, and show steady improvement in quality and performance.
• Collaborate with team members and communicate effectively while maintaining focus on quality and productivity.
• Participate in on‑the‑job training and apply feedback from supervisors to continuously improve skills and output.

• Ability to work under a microscope for long periods of time while maintaining focus and accuracy.
• Comfort using small hand tools to assemble tiny components in a precise and controlled manner.
• Willingness and physical ability to work long hours when required, including extended shifts and overtime.
• Strong attention to detail and commitment to producing high-quality, defect‑free work.
• Reliable attendance and dependability in following schedules and meeting production expectations.
• Ability to follow written and verbal instructions carefully and consistently.
• For R&D assemblers: ideally 1–2 years of experience in medical devices (catheters preferred) or related industries such as electronics.
• For line assistants: ability to work within computer systems, including ERP platforms, to manage work orders and inventory transactions.
• For line assistants: capability to perform cycle counts and basic inventory control tasks in a cleanroom environment.
• Willingness to learn and follow Good Documentation Practices (GDP) and regulated manufacturing procedures.

• No prior experience required for entry‑level assembler roles; the company provides full on‑the‑job training.
• Experience in medical device manufacturing, electronics assembly, or similar precision assembly environments is a plus.
• Familiarity with cleanroom protocols, gowning procedures, and contamination control is beneficial.
• For R&D assemblers: experience working in a lab environment rather than a traditional production cleanroom is an advantage.
• For R&D assemblers: skills with coils, hot boxes, iron soldering, UV bonding, and measuring tools such as rulers, VIS, snap gauges, calipers, and micrometers are highly desirable.
• Comfort working with computer‑based systems for documentation, work orders, and inventory is helpful, especially for line assistant roles.
• Ability to work effectively in a team‑oriented environment and maintain positive working relationships.
• Openness to feedback and a desire to grow into…