Medical Device Production Lead Assembler - 1st shift
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Performs fabrication of BioTrace pacing lead sub-assemblies and final lead assembly per established Manufacturing Process Instructions. Responsible for supervision of the production staff and for achieving BioTraces production build plan. Has the authority to identify and record problems relating to product component design, device manufacture and recommend solutions. Adheres to established company quality system procedures and timelines for all product builds.
GENERAL DUTIES AND RESPONSIBILITIES:
Supervise production process
Train and manage production staff
Control materials coming into production areas to assure traceability
Segregate all non-conforming parts/products
Manage supplies inside cleanroom
Insure line clearance at the beginning and end of each new lot
Monitor and report on production status on daily basis
Monitor production and test equipment to assure timely calibration
Monitor and insure that adequate equipment is in place to perform the process efficiently and with highest quality
Perform LHR review
Adhere to BioTrace Medicals Quality Policy and Good Manufacturing Practices
Support company goals and objectives, policies and procedures, the QSR, and other FDA/MDD regulations
Perform strict adherence to established Manufacturing Process Instructions
Recording of accurate information into the Lot History Record for all product builds
Provide open communications and feedback to Operations management related to progress of all product builds
Identify manufacturing and/or process challenges to improve fabrication techniques, quality or efficiency of product builds
SPECIFIC COMPETENCIES:
Demonstrated manual proficiency working under a microscope (10x-30x) to prepare and assemble complex and precision catheter components and sub-assemblies, and final catheter assembly at the scale of a 6F or smaller catheter.
Relevant experience:
Assembly of intravascular guide wires
Assembly of PTCA or PTA catheters
Assembly of atherectomy catheters
Demonstrated examples of working with the following tools and processes:
Micro-crimpers and crimping operations
UV bonding adhesives and UV light source
Hypotube hole cutters
Assembly of micro-subassemblies into the scale of a 6F catheter system
Preparation of micro-hypotubes for assembly into final catheter
EDUCATION REQUIREMENTS:
High school diploma or GED required.
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EXPERIENCE REQUIREMENTS:
Minimum 5 years medical device industry experience in the fabrication of micro-catheters preferable.
OTHER QUALIFICATIONS:
Working knowledge of GMP (Good Manufacturing Practices) and cleanroom protocol.
Excellent manual dexterity.
Flexibility with respect to work hours as some overtime work may be required.
Proficient spoken and written English.
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