Job Description
Job Overview
The Manufacturing technician will be responsible for production and post-processing of medical devices. Common secondary processes include deburring, Mirror Polishing, media blasting, filing, cleaning, and packaging.
Essential Duties and Responsibilities:
- Duties and responsibilities
- Perform production activities for equipment set-up/line clearance, processing, labeling, and record completion while following quality system guidelines and Good Manufacturing Practices (GMP)
- Support equipment maintenance activities as needed
- Participate in continuous improvement projects
- Perform inspections for components and product at all stages of manufacturing process
- Compliance to safety (OSHA), GMP, GDP, GLP and 21 CFR 820.
Qualifications and Experience:
- High school diploma or GED required
- Associates or post-secondary education preferred
- Experience in the use Rotary tools, Die Grinders, is required
- Experience in the use of basic machine shop tools and equipment is required
- Mechanically inclined
- Working knowledge of GMP, GLP, and GDP is required
- Strong verbal and written communication
- Experience in FDA 21 CFR 820 Quality system is preferred
Tools and Equipment
- Position may involve the use of:
- Basic hand tools
- Rotary tools
- Media blasting cabinet
- Cleaning and inspection equipment
- Sealing and packaging equipment
- Respirator, protective clothing, eye protection, and hearing protection
- Position may involve handling of or exposure to metallic powders and other powered materials, mill coolant, tapping fluid, polymeric resins, cleaning solutions, inert gases, and acids.
Physical Activities
Skills, Abilities, Competencies Required:
- Position requires the ability to intermittently lift and carry up to 50 pounds
- PPE including eye protection, hearing protection, and gowning required depending on task performed
- May require extended periods of standing, extensive work with the operator’s hands and tools, as well as occasional squatting, kneeling, and working with a ladder
- Working conditions include standard conditions of a machine shop. Machine shop conditions may include noise, dust, and temperature extremes.
- Working conditions may also include working in a clean room environment. Clean room environment will require wearing PPE – Gown, hair net, shoe covers and nitrile gloves.
restor3d is an equal opportunity employer