Laboratory Technician - Medical Device Manufacturing Assembler
huMannity Medtec
Position Summary The Lab Technician is responsible for precision micro-electronic assembly, testing, inspection, and documentation of medical device components in a regulated R&D and production laboratory and cleanroom environment. This role requires expert-level hand soldering skills, strong manual dexterity for microscopic assemblies, strict adherence to quality standards, and the ability to work collaboratively with Engineering throughout the product lifecycle. This position operates within a cleanroom and GMP-regulated environment and plays a critical role in ensuring product quality, traceability, and compliance with company SOPs and medical device regulations. You will contribute to life-changing medical technologies in a collaborative, innovation-driven environment. This role offers hands‑on technical engagement across the full product lifecycle in a highly respected and regulated medical device setting. Note: This is a full-time, on-site position, not a generally hybrid or work‑from‑home schedule. Key Responsibilities Electronics Assembly & Manufacturing Perform precision hand soldering of electronic components (IPC certification preferred). Assemble micro-electronic and hybrid components using conductive and non-conductive epoxies. Assemble components with brazing, laser and/or resistance welding. Install surface mount components (e.g., 0201, 0402). Perform mechanical assembly including crimping, staking, screwing, welding, press‑fitting, and bonding. Conduct potting, encapsulation, sanding, cleaning, epoxy bonding, curing, and related assembly tasks. Perform assembly under low- and high-power microscopes. Work with ESD-sensitive, small, delicate assemblies. Testing & Troubleshooting Set up and perform electrical testing using automated and semi-automated test equipment. Conduct inline go/no-go testing and inspection. Troubleshoot electronic components and circuit boards. Trim or adjust materials to meet specified electrical or dimensional requirements. Quality & Compliance Follow Standard Operating Procedures (SOPs), Work Instructions, and Device Work Instructions (DWIs). Ensure full traceability through accurate documentation and completion of work orders, travelers, DHRs. Perform incoming, in-process, and final inspections (visual, electrical, mechanical). Inspect personal and peer work to ensure compliance with quality standards. Maintain compliance with: ISO 13485 FDA 21 CFR Part 820 ISO 9001 GMP requirements Collaboration & Engineering Support Work directly with Engineering during concept, R&D, and production phases. Provide real-time manufacturability feedback. Assist in drafting and improving manufacturing documentation. Suggest and implement process improvements to improve yield, scrap reduction, and cycle time. Lab & Equipment Support Maintain cleanroom, lab, and stockroom to GMP standards. Support inventory coordination and materials management. Track and coordinate calibration activities. Perform preventative maintenance and ESD testing. Monitor process equipment (data loggers, chart recorders, etc.). Qualifications Exceptional manual dexterity (bilateral hand use). High attention to detail and documentation accuracy. Strong troubleshooting ability. Dependable, punctual, and accountable. Ability to adapt to shifting priorities in an R&D environment. Positive, collaborative team mindset. Clear communication with engineers and cross-functional teams. Education & Experience High school diploma or GED required. 5–10+ years of experience in medical device manufacturing or other highly regulated industries (aerospace, automotive, defense, consumer electronics). Expert-level hand soldering skills (IPC-A-610 certification strongly preferred). Experience working under microscopes with micro-electronic assemblies required. Strong understanding of ESD-sensitive assemblies. Ability to read schematics, blueprints, and technical drawings. Experience with PC boards, cabling, and precision tooling. Computer literate with basic data entry skills and Microsoft Office Suite. Nice To Have (Preferred But Not Required) Resistance or laser welding (hermetic/spot welds) Brazing (ceramic-to-metal, metal-to-metal) Casting and molding Mechanical assembly experience Sample preparation for engineering analysis (cross-sectioning, X-ray) Experience with epoxy systems and specialty adhesives Mil-Std soldering (including ROHS) Work Environment Cleanroom and laboratory environment(s) with appropriate PPE. Use of microscopes and precision tools with both hands free to assemble and inspect miniature components and assemblies. Handling of ESD-sensitive components. Standing, sitting and fine motor work for extended periods. 9/80 Schedule #J-18808-Ljbffr
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