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