Technical Associate / Manufacturing Technician at Surgilum, LLC

Surgilum is seeking a skilled and detail-oriented Technical Associate to support Research, Design and Manufacturing activities. The ideal candidate is a hands-on, self-starter with general knowledge of mechanical, electrical, and optical system design and manufacturing. Candidate must be attentive to detail and have a passion to complete tasks. Role requires a “maker” mindset. Success in the role will require resourcefulness and creativity in balance with discipline to maintain appropriate records and communication. The position is a full-time and on-site opportunity at Surgilum’s facility in downtown Wilmington. Facility hours are weekdays, 9a to 5p. Surgilum offers competitive salaries commensurate with experience. Required Qualifications: - Associate's degree in biomedical engineering, electronics, mechanical engineering, or a related field - 2-4 years of experience in medical device manufacturing or a related field. - Knowledge and competence with fundamental manufacturing and quality processes. - Experience, education, or knowledge/competence in using CAD systems (i.e. Solidworks, AutoCad/Autodesk, Rhino3D). - Computer literacy including basic competency with e-mail, word processing (i.e. MSWord), spreadsheets (i.e. Excel) and file management. - Experience and competence in applying internet resources to constructive knowledge search and research. Desired Qualifications: - Experience working in a medical or other compliance regulated environment, especially under an ISO 13485 or ISO 9001 Quality System. - Experience in electronic assembly with knowledge of soldering technologies and processes, especially to Workmanship Standard IPC-A-610. - Experience and/or knowledge with metal fabrication, machining injection molding processes (especially CNC turning and milling). - Experience in using and maintaining manufacturing tools and equipment including 3D printers. - Experience and/or knowledge of basic electronics and microprocessor systems. Ability to troubleshoot electronic circuits a plus. Required Competencies & Skills: - Strong analytical thinking to identify opportunities to improve processes and productivity. - Ability to diagnose equipment malfunctions efficiently. - Ability to read and interpret technical drawings and schematics. - Excellent verbal and written communication skills to interact with engineers, management, and quality personnel. - Ability to document processes, repairs, and maintenance activities clearly and accurately. - Meticulous approach to work, ensuring compliance with quality standards and regulatory requirements. - Willingness to learn new technologies and processes. - Strong interpersonal skills to work in a small company environment.- Ability to spot flaws in products or problems with equipment. - Ability to troubleshoot technical issues and implement corrective actions. Desired Competencies & Skills: - Understanding of Good Manufacturing Practices (GMP) and quality control procedures. - Understanding of FDA regulations, ISO standards (particularly ISO 13485), and other relevant regulatory frameworks. - General understanding of medical device design requirements, especially devices for ophthalmic procedures. - Knowledge of design control processes and risk management principles. - Knowledge of inventory management and supply chain processes Employment Type: Full Time Years Experience: 1 - 3 years Salary: $25 - $35 Hourly Bonus/Commission: No