Essential Job Duties and Responsibilities
- Assist in sustaining manufacturing processes by supporting troubleshooting, documentation, and continuous improvement activities.
- Support execution of validation and qualification protocols (IQ/OQ/PQ) for equipment, processes, and design changes.
- Collaborate with engineers to identify and implement process improvements that enhance safety, quality, and throughput.
- Participate in engineering change order (ECO) documentation, test execution, and implementation activities.
- Help analyze production data, perform basic statistical analysis, and summarize findings in reports.
- Observe and participate in root cause analysis activities and nonconformance investigations.
- Learn and apply Lean and Six Sigma principles to reduce waste and improve efficiency.
- Participate in design reviews and contribute DFM (Design for Manufacturability) input under guidance.
- Assist in drafting technical documents, validation plans, and troubleshooting guides.
- Learn quality and regulatory standards applicable to medical devices, including FDA QSR and ISO 13485
Education and Experience Requirements
- Pursuing a Bachelor’s degree in Mechanical, Industrial, Manufacturing, Biomedical Engineering, or related field.
- Previous internship, co-op, or project experience in regulated manufacturing or medical device environment is a plus.
Required Skills and Abilities
- Strong organizational and time management skills with the ability to independently complete assigned tasks.
- Strong interest in medical device manufacturing and continuous improvement.
- Effective written and verbal communication skills.
- Detail-oriented and self-motivated with the ability to follow directions and ask questions.
- Familiarity with Microsoft Office (Word, Excel, PowerPoint); exposure to SolidWorks or CAD is preferred.
- Basic understanding of root cause analysis, data analysis, and engineering documentation.
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