Position Summary.

The Assembly Technician I will manufacture instrumentation and/or consumables, working within established SOPs to develop and follow best processes for product assembly and inventory management.

Essential Duties and Responsibilities. 

• Perform Line Clearances and set-up the production line
• Document/Record activities and data on Batch Records/Device History Records (DHRs)
• Ensure completeness and accuracy of Batch Records/DHRs
• Assemble products following technical instructions and drawings/specifications
• Discern quality of parts and materials used in production
• Inventory parts and tools used in the assembling process
• Follow company Standard Operating Procedures (SOPs) and directives
• Help improve processes and provide feedback to ensure better output
• Test and inspect finished products for quality defects
• Maintain the tools used to create products

Keep a clean and well-maintained workspace and equipment

Education, Qualifications, and/or Experience. 

• High school diploma or equivalent required
• At least 1 year of assembly experience preferred or 2 or more years of work in collaborative work environment with trained or instruction-based work responsibility.
• Prior experience working in an FDA regulated or ISO manufacturing environment with GMP knowledge preferred
• Ability to follow protocols, written instructions, SOPs while adhering to quality standards and requirements
• Basic computer skills, including MS Office, internet and email
• Possess excellent hand-eye coordination with an attention to detail
• Flexibility to handle changing needs and demands, as well as navigate process improvements
• Ability to set up and operate small, automated machinery with training and hand tools

• Experience working with small and intricate parts

• Must possess strong teamwork skills and work well with others

Physical Requirements.  

• Repetitive Motion: Mostly computer use
• Weight Lifting: < 25 lbs
• Ability to sit or stand for extended periods of time
• Must possess good communications skills
• Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas