Production & Assembly Technician

Job Description

Role and Responsibilities:

• Receive, inspect, and verify incoming materials and components prior to assembly.

• Assemble systems and subsystem components according to approved manufacturing protocols, work instructions, and engineering drawings.

• Perform precise and delicate assembly tasks using manual tools, fixtures, and microscopes.

• Carry out all relevant processes within a cleanroom environment while adhering to gowning procedures, contamination‑control practices, and ISO 13485 requirements.

• Complete Device History Records (DHR), batch records, and all required production documentation accurately and in compliance with GMP/GDP standards.

• Identify issues, perform basic troubleshooting, and report defects or deviations to engineering or quality teams.

• Operate production equipment, microscopes, measurement tools, and assembly fixtures safely and effectively.

• Monitor assembly processes to ensure compliance with production specifications, tolerances, and quality standards.

• Handle and assemble delivery systems/catheters, including lumen threading, bonding, flushing, and functional verification.

• Follow all safety procedures, including chemical handling, equipment safety, and ergonomic guidelines.

Preferred Skills:

• Relevant technical / mechanical background

• Experience with Delivery Systems & Familiarity with various assembly technologies

• Experience with working in a Cleanroom environment & Experience with collaborating with engineering team.

• Experience working under GMP requirements

• Experience working according to ISO 13485

• Ability to work under pressure with strong organizational skills, attention to detail, and accuracy

• Ability to work independently as well as part of a team