Medical Device Production Assembler - 3rd shift, full-time contract 


Performs fabrication of BioTrace pacing lead sub-assemblies and final lead assembly per established Manufacturing Process Instructions. Adheres to established company timelines for all product builds

GENERAL DUTIES AND RESPONSIBILITIES:

  • 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 both Operations Director and V.P. of R&D related to progress of all product builds, and any issues that may affect the quality and/or progress of each product build, consistent with the company timeline.

  • Identify manufacturing and/or process challenges to improve fabrication techniques, quality or efficiency of product builds.

  • Adhere to BioTrace Medical’s Quality Policy and Good Manufacturing Practices.

  • Support company goals and objectives, policies and procedures, the QSR, and other FDA/MDD regulations.

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 catheter (0.080” catheter diameter) or smaller. Relevant experience :

  • Assembly of intravascular guide wires (0.014” and/or 0.035”)

  • 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 the final catheter (holding & cutting to length using pin vices and Dremel tool)

  • Expansion of catheter lumen using heat gun and mandrels

  • Experience using

  • Dremel tools

  • Analog and digital calipers

  • UV cure systems

  • Electronic flow dispensing system

EXPERIENCE/EDUCATION REQUIREMENTS:

  • Minimum 5 years medical device industry experience in the fabrication of micro-catheters preferable.

  • Some experience in Research and Development desirable.

  • High school diploma required.

OTHER QUALIFICATIONS:

  • Working knowledge of GMP (Good Manufacturing Practices) and cleanroom protocol.

  • Excellent manual dexterity

  • Flexibility with respect to work hours as some evening/weekend work may be required.

  • Proficient spoken and written English

  • Must sign BioTrace confidentiality agreement.