NPI Engineer

AuST Group is a privately held, rapidly growing medical device innovator. We specialize in the design and manufacture of advanced interventional technologies, with a primary focus on the cardiovascular, pulmonary, and endoscopy markets. At AuST, we blend technical precision with entrepreneurial agility to deliver life-saving solutions to clinicians worldwide. The NPI Engineer is responsible for leading the transition of new medical device products from design and development into full-scale manufacturing. This role works cross-functionally with R&D, Quality, Supply Chain, Regulatory, and Manufacturing teams to ensure products are launched on time, meet compliance requirements, and are scalable for production.

The Role:

Managing internal and external activities associated with design transfer (project management). Work with manufacturing, quality, and engineering to ensure safe, efficient manufacturing of medical devices. Ensuring all testing and regulatory requirements are met. Conduct root cause analysis and develop timely solutions for issues that may arise. Write and execute process validation protocols. Set up new manufacturing lines with efficient workflow and lean manufacturing principles. Work with minimum supervision, prioritize and manage workload, and complete tasks on schedule.

Key Skills and Experience:

Project management experience. Experience with design controls, DV&V and design transfer activities. Experience in manufacturing environment. The ability to work with minimum supervision, prioritize and manage workload, and complete tasks on schedule. Strong oral and written communication skills along with proficiency in Microsoft Office Suite. Ability to write technical reports, business correspondence, technical and administrative procedures. Strong team player, works well with all levels of employees, collaboratively and respectfully in a team environment.

Responsibilities:

Design manufacturing processes for new products then justify, implement and validate solutions to accomplish cost, quality and schedule goals. Represent engineering on new product cross-functional teams to accomplish design for manufacturability goals to ensure compliance with good manufacturing practices, safety, quality standards, and customer needs. Manage the transfer of projects successfully from R&D into manufacturing Interface with external test labs to support and manage required tests for Design Verification and Design Transfer activities. Develop manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures that support a Lean manufacturing environment. Develop and maintain the documentation necessary to ensure the consistent manufacture of products (processes, drawings, routings, and maintenance). Provide engineering support for troubleshooting of process or product issues, including root cause failure analysis of discrepant materials and assemblies, including CAPA activities. Write and perform electrical, mechanical, material and equipment tests, gather data, interpret results, and write reports. Specify and procure equipment and oversee outside vendor activity as required. Successfully works with new technologies and methods on new designs and upgrades to existing designs. Coordinate with both R&D and Manufacturing teams to ensure all Design Verification and Design Validation activities are completed to support regulatory filings. Complete process validations to meet applicable FDA and regulatory requirements.

Note:

This employee may be requested to follow other job-related instructions and to perform other job-related duties subject to all applicable state and federal laws

Job Type:

Full-time Benefits:

401(k) 401(k) matching Dental insurance Flexible schedule Flexible spending account Health insurance Health savings account Life insurance Paid time off Parental leave Relocation assistance Retirement plan Vision insurance Ability to

Commute:

West Valley City, UT 84119 (Required)

Work Location:

In person