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
