Manufacturing Technician

30-person commercial-stage medical device startup seeking a hands‑on Manufacturing Technician to support the production, testing, and assembly of our innovative gastrointestinal implant and delivery system. This individual will play a critical role in building medical devices, supporting manufacturing process development, troubleshooting production issues, and helping scale operations as the company continues commercial growth. The ideal candidate enjoys working in a fast‑paced startup environment, takes pride in producing high‑quality products, and is comfortable working closely with Manufacturing, Engineering, and Quality teams. Responsibilities Perform assembly, inspection, testing, packaging, and labeling of medical device components and finished products according to approved procedures and work instructions. Support manufacturing operations for both implantable devices and catheter/delivery system products. Maintain accurate production records, Device History Records (DHRs), travelers, and associated manufacturing documentation. Operate and maintain production equipment, fixtures, tools, and test systems. Assist Manufacturing Engineers with process development, validation activities, and continuous improvement initiatives. Identify, troubleshoot, and communicate manufacturing issues, non‑conformances, and equipment problems. Ensure compliance with FDA Quality System Regulations, ISO 13485 requirements, and company quality procedures. Assist with inventory management, material handling, and production scheduling activities as needed. Support manufacturing scale‑up efforts as production volumes increase. Required Qualifications 4 - 6+ years of experience in medical device, life sciences, or other regulated manufacturing environments. Medical device manufacturing experience. Experience working in an ISO 13485 and/or FDA‑regulated environment. Strong mechanical aptitude and experience using hand tools, fixtures, and manufacturing equipment. Ability to read and follow detailed work instructions, drawings, and assembly procedures. Experience documenting work accurately and maintaining production records. Strong attention to detail and commitment to quality. Comfortable working in a team‑oriented startup environment. Ability to stand for extended periods and perform repetitive assembly tasks. Preferred Qualifications Experience with catheter assembly, implantable devices, or precision mechanical assemblies. Familiarity with cleanroom manufacturing practices. Experience supporting IQ/OQ/PQ validations and process verification activities. Basic understanding of GMP, Design Controls, and manufacturing documentation requirements. Soldering, adhesive bonding, crimping, laser marking, or similar precision assembly skills. Key Attributes Hands‑on and mechanically inclined. Detail‑oriented with strong quality focus. Self‑motivated and dependable. Able to work effectively in a growing startup environment. Strong English communication and teamwork skills. Eager to learn new processes and technologies. Local Candidates only Must Have US Work Authorization, no VISA sponsorships #J-18808-Ljbffr