AuST Group is both a premier medical device design and development firm and a high-volume manufacturer of components and finished devices. We bring broad experience in minimally invasive technologies and deep expertise in 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 looking for a Senior NPI Engineer to play a pivotal role in transforming innovative designs into life-saving products. In this position, you’ll be at the center of new product introduction to ensure smooth transfer from development to manufacturing while balancing regulatory, engineering needs.
Join our team and shape the future of manufacturing innovation!
Key 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
Qualifications:
- Bachelor’s degree in mechanical engineering, manufacturing engineering, industrial engineering, or material science engineering. Master's degree is preferred.
- Knowledge of working with medical device regulations CFR 820 & ISO13485. Experience is preferred.
- Knowledge of material in plastics, injection molding, and press-forming
- Demonstratable analytical skills, with experience in root cause analysis and structured problem-solving, including statistical analyses, DOE, etc.
- Excellent interpersonal and communication skills to collaborate effectively across multi-functional teams. Bilingual in Spanish is preferred.
- Certification in Lean or Six Sigma methodologies is a distinct advantage.
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Relocation assistance
- Retirement plan
- Vision insurance
Work Location: In person
