Electromechanical Assembler

Job Description

Job Description

Description:

Duties / Responsibilities:
• Set up, calibrate, and operate basic manufacturing equipment in accordance with production schedules and quality standards.
• Assemble electromechanical subassemblies and finished medical devices, including handling small precision components.
• Perform functional and electrical testing using automated equipment and manual instruments (oscilloscope, multimeter, function generator).
• Troubleshoot technical issues related to product lines and manufacturing processes to minimize defects; escalate complex issues as needed.
• Conduct electrical testing of medical device hardware in compliance with regulatory and quality standards.
• Support rework, repair, servicing, and refurbishment of nonconforming products.
• Perform routine and preventive maintenance on production equipment; document activities in CMMS (InforEAM).
• Maintain accurate production and quality documentation, including Device History Records (DHR), ensuring traceability and compliance.
• Utilize electronic systems and software tools for data collection and production tracking.
• Adhere strictly to FDA regulations, Quality Management System (QMS), and Environmental Health & Safety procedures.
• Support engineering initiatives such as process validation, continuous improvement, and new product introduction (NPI).
• Identify opportunities to improve manufacturing efficiency, yields, and productivity.
• Manage priorities across multiple product lines with minimal supervision.
• Provide cross-functional support and training to team members as needed.
• Communicate effectively with manufacturing, engineering, and quality teams.
• Interpret technical documents including SOPs, work instructions, and engineering drawings.
• Support audits, inspections, and collaborate with internal teams, vendors, and contractors.
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Experience:
• Typically 0–2 years of relevant manufacturing or production experience (medical device or regulated industry preferred).
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Key Skills:
• Electromechanical assembly
• Troubleshooting and problem-solving
• Electrical testing and inspection
• Use of test equipment (oscilloscope, multimeter, etc.)
• Attention to detail and documentation accuracy
• Ability to follow SOPs, drawings, and technical instructions
• Knowledge of GMP/FDA-regulated environments
• Computer/data entry skills
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Preferred Experience:
• Medical device or highly regulated manufacturing environment
• Experience with cleanroom operations
• Familiarity with CMMS systems (InforEAM)
• Exposure to QMS, EMS, and compliance standards
• Continuous improvement or lean manufacturing experience
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Education:
• High school diploma or GED required
• Technical certification or associate degree in electronics, manufacturing, or related field preferred