Medical Device Assembly Technician

AVS is an early‑stage medical device company that is focused on safely and effectively treating severely calcified arterial disease. AVS is the first company to develop pulsatile intravascular lithotripsy (PIVL®), a therapy that is delivered through a balloon‑based platform called the Pulse IVL® System. It is designed to be the only minimally invasive technology that gently shatters calcium and opens the artery using a single device.

We are currently seeking an Assembly Technician to join our team!

• Assembly and manufacture of the Pulse IVL® device in accordance with quality system requirements, manufacturing procedures, and manufacturing instructions.
• Perform or assist in receiving materials, in‑process product, and final product inspection/test.
• Participate in development and review of manufacturing procedures to help ensure manufacturing requirements and goals are met.
• Assist in development of manufacturing instructions that document and control the manufacturing process.
• Support the development of manufacturing tools and fixture requirements and promote ongoing control.
• Assist with the training of manufacturing area personnel, as required.
• Assist in the deployment of product changes and the development of facility requirements to accommodate production, including workflow, shelving, other storage, and workstations.
• Participate in the review of packaging and shipping requirements so the product can be transported without damage.
• Provide feedback to Engineering personnel concerning manufacturing needs and product enhancements that would improve both quality and ease of manufacturing/servicing of the product.
• Interface and support regulatory affairs as required to help ensure production processes and facilities are in accordance with FDA, OSHA and other applicable regulations.
• Ensure safety and quality considerations and requirements are proactively addressed and implemented in the production process.
• Follow GMP requirements while maintaining neat and organized workstations during the assembly process.

• Associate degree in production, manufacturing engineering, general engineering field, or at least three years’ experience working in Medical Device manufacturing.
• Prior Experience with the following:
• Interpretation and use of product design drawings and related documentation.
• Operating in heavily documented and controlled production processes.
• Product testing and understanding of calibration control.
• Strong written and verbal communication skills, with all levels of employees, suppliers, and customers
• Experience with personal computer systems, including word processing, spreadsheet reports, and E‑mail.
• Experience with safety and health (OSHA), FDA and ISO 9001 quality system requirements.
• Must be able to regularly lift and/or move physical inventory weighing up to 50 pounds.
• Must be able to spend long periods of time standing