Cleanroom Assembler

Cleanroom AssemblerThe Cleanroom Assembler operates and maintains small production equipment in a controlled cleanroom environment to produce high-quality medical device products. This role focuses on small component assembly under a microscope, light soldering, and precise inspection work, while consistently meeting documentation, GMP, and quality standards.ResponsibilitiesOperate and maintain small production equipment safely to produce high-quality products in a cleanroom environment.Perform small component assembly under a microscope, including light soldering and detailed hand work.Complete component assembly, inspection, and related production duties according to established procedures.Meet all documentation requirements by accurately completing and filing paperwork associated with assemblies, products, and processes.Maintain a clean and organized work area that supports efficient production and complies with cleanroom standards.For spherz products, perform all production processes including forming, cutting, punching, assembly, packaging, and sealing.Complete production processes in full compliance with established documentation requirements and GMP standards.Inspect, evaluate, and accept product in accordance with documented QA standards and procedures.Work with robotics and other production machines in the cleanroom as part of the assembly and inspection process.Collaborate effectively with team members while maintaining a strong work ethic and consistent productivity, even when working independently.Essential SkillsHands-on experience in assembly, production, machine operation, or general manufacturing.Experience in a GMP-regulated environment or strong willingness to learn and adhere to GMP regulations.Strong attention to detail and accuracy when working with small components and documentation.Manual and hand dexterity for fine component assembly, deburring, and precise handling of materials.Ability to read and interpret blueprints and follow documented procedures.Comfort working under a microscope for small component assembly and inspection.Ability to perform light soldering in accordance with relevant standards (such as IPC/J-STD).Capability to work independently without direct supervision while maintaining high productivity.Mechanical aptitude and comfort handling component assembly and basic production equipment.Reliable inspection skills to evaluate and accept product against QA standards.Additional Skills & QualificationsExperience as a production operator, machine operator, assembler, or in general manufacturing is preferred.Prior exposure to medical device manufacturing or medical assembly environments.Familiarity with cleanroom operations and cleanroom protocols.Experience working with packaging machinery and production equipment.Knowledge of IPC, J-STD, or similar industry standards for soldering and electronic assembly.Ability to work with robotics equipment in a cleanroom setting.Strong teamwork and communication skills, with the ability to fit into a collaborative, high-performing group.Proactive, hardworking approach and commitment to maintaining a positive team rhythm.Why Work Here?You will join a rapidly growing organization that has significantly expanded its revenue, product lines, and cleanroom capacity in recent years. The company invests in new technologies and acquisitions, bringing additional products in-house and creating opportunities for advancement across multiple departments. Team members who perform well can learn new tasks, move into other areas of the business, and grow their careers in a stable, forward-looking environment that values strong work ethic, collaboration, and continuous improvement.Work EnvironmentThis role is based in a very clean, climate-controlled manufacturing facility with an expanded cleanroom and warehouse space. Work is performed in a cleanroom environment that requires strict adherence to GMP regulations and documented procedures. You will work with microscopes, robotics machines, production and packaging equipment, and other tools used in medical device manufacturing. The primary products manufactured at this site include spherz used in MRI to assist neurosurgery, surgical needles for bone operations, and radiation cages for cancer patients. The standard schedule is second shift, Monday through Thursday, from 10:00 a.m. to 8:00 p.m., with initial training on first shift for one to two weeks on flexible hours such as 5:00 a.m.–1:00 p.m., 6:00 a.m.–2:00 p.m., or 7:00 a.m.–3:00 p.m.