AuST Group is a medical device design and development firm with broad experience relating to minimally invasive devices and deep expertise relating to cardiovascular catheters. “AuST” is a name symbolizing the gold (Au) standard (ST). We strive to deliver the gold standard in everything we do.
We’re seeking a Staff Development Line Manufacturing Engineer to refine processes, support early-stage builds, and drive smooth transitions from development to commercial production.
This position will provide engineering support for manufacturing processes and equipment for products that are in development, produced in small volumes for clinical trials and/or ready to be transferred to the commercial manufacturing group. The position will independently create projects and execute to create an appropriate level of manufacturing rigor that is development stage appropriate depending on product, but also work collaboratively and support manufacturing director with change orders and investigations. This position may have a manufacturing technician and junior support staff report to them and provide guidance to the small operations team that builds product.
This position is responsible for the DMR refinement (after creation by development engineer), monitoring early development builds with eagle eye, assessing development processes for opportunities to improve and judiciously improving those of sufficient stage appropriate value. This position will ensure that work instruction, manufacturing record elements, quality inspection, and equipment qualification/maintenance are adequate to support consistent and appropriate manufacturing methodology. They will coordinate/drive/create equipment enhancements or new tooling needed to make processes more efficient. This position will work closely with dev engineering and new product introduction engineering to ensure seamless transition between teams.
They will understand product inspection and can validate test methods as required, but also implement and train verification steps where validation cannot be performed. This position will drive to optimize existing manufacturing processes and equipment and ensure new products are designed for manufacturability (inclusive of process validations). Product investigation (root cause analysis) is imperative to the success of this individual to contribute to better processes or support NCs or CAPAs.
Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Ability to Commute:

• West Valley City, UT 84119 (Required)

Ability to Relocate:

• West Valley City, UT 84119: Relocate before starting work (Required)

Work Location: In perso

Please refer the Job description for details