What are the responsibilities and job description for the Medical Device Assembly Technician position at Amplitude Vascular Systems?
Company Overview:
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!
Scope & Responsibilities:
- 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.
Skills and Qualifications
- 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