Engineering - Non Degreed I

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.
________________________________________
Experience:
Typically 0 2 years of relevant manufacturing or production experience (medical device or regulated industry preferred).
________________________________________
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
________________________________________
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
________________________________________
Education:
High school diploma or GED required
Technical certification or associate degree in electronics, manufacturing, or related field preferred