Manufacturing Associate

Manufacturing Associate

The Manufacturing Associate is responsible for the production of quality medical devices. This position supports Production and Logistics by performing and documenting daily manufacturing operations that involve operation of various process equipment and other tasks in support of the production schedule. This person will comply with safety requirements, current Good Manufacturing Practices and Standard Operating Procedures and coordinate the cleaning, assembly and preparation of equipment and final products according to written instructions.

The position will further support P&L by maintaining raw material stock, cleanroom readiness and final product inventory.

• Perform daily manufacturing steps required to produce Embody’s medical devices.
• Maintain the integrity of ISO class 7 & 8 Clean rooms by performing proper gowning, entry and cleaning procedures.
• Perform in-process quality checks on sub-assemblies and finished products.
• Inspect, label, package and ship final products.
• Perform daily equipment checks and preventive maintenance per established procedures.
• Utilize small hand tools, calibrated instruments, measurement equipment, and test fixtures.
• Clean equipment, labware and manufacturing areas in accordance with SOPs.
• Maintain raw material inventory and perform incoming inspections.
• Assist in ongoing process improvement and subsequent validation activities.
• Participate in line and production planning meetings as needed.
• Work with engineers, technicians and management to resolve line issues and suggest improvements.
• Maintain accurate records and documentation related to quality, work in progress, test results and special projects.
• May interact with external customer contacts, including participating in tours for visitors including VIPs and may be questioned and/or observed during audits.
• Adhere to general safety rules, manufacturing procedures, company policies and procedures, ISO and FDA regulations.

• High school diploma or equivalent.
• Minimum (2) years working in a manufacturing environment, preferably within the medical device or tissue banking industry.
• Minimum (2) years working with an electronic manufacturing and inventory system such as Fishbowl or SAP.