Engineer

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.

* 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.

* Typically 0-2 years of relevant manufacturing or production experience (medical device or regulated industry preferred).

* 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

* 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

* High school diploma or GED required

* Technical certification or associate degree in electronics, manufacturing, or related field preferred