Job Summary:The Manufacturing technician will be responsible for production and post-processing of medical devices. Common secondary processes include deburring, media blasting, polishing, filing, cleaning, and packaging.Essential 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:
- High school diploma or GED required
- Associates or post-secondary education preferred
- 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
- Basic hand tools
- Rotary tools
- Polymeric 3D printers
- Media blasting cabinet
- Furnace or ovens
- Materials testing frames
- Cleaning and inspection equipment
- Sealing and packaging equipment
- Respirator, protective clothing, eye protection, and hearing protection
MATERIALS HANDLING / EXPOSUREPosition may involve handling of or exposure to metallic powders and other powder materials, polymeric resins, cleaning solutions, inert gases, and acids.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. Work environment may also include a controlled environment requiring the technician don PPE such as gown, hair net, shoe covers and nitrile gloves.
restor3d is an equal opportunity employer