Medical Device Assembler

Job Description

Job Description

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

· 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