Assembly Technician - Austin, United States - Nuclein
Description
About Nuclein:
Nuclein is an Austin-based, private equity funded, medical device company that offers an innovative, FDA EUA authorized, rapid PCR, point-of-care system.
Our vision
is to enable simple, affordable, rapid and accurate testing for everyone.
We are a dedicated, talented and diverse team of scientists, engineers and experienced professionals who are driven to excel and make a significant contribution to the world.
At Nuclein, we offer a fast-paced, exciting, collaborative environment where individual contributions are highly valued as we work to expand the use of our transformative testing technology in the market.
Position Summary:
The Assembly Technician will manufacture instrumentation and/or consumables, working within established SOPs to develop and follow best processes for product assembly and inventory management.
Responsibilities:
- Perform Line Clearances and setup 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 wellmaintained workspace and equipment
Qualifications**:
- High school diploma or equivalent required
- At least 1 year of assembly experience required, prior cleanroom and 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
- Possess excellent handeye 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
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