Assembly Technician II - Instruments

Position Summary.

The Assembly Technician II 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

• Interpret engineering blueprints and technical terms

• 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 5 years of electro-mechanical assembly experience required

• At least 2 years prior medical device experience preferred

• Prior experience working in an FDA regulated or ISO manufacturing environment with GMP knowledge preferred

• Ability to follow strict protocols and adhere to quality standards

• Ability to read and understand manufacturing instructions and SOPs

• 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

• 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