Regulatory Compliance Engineer

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 Regulatory Engineer to play a pivotal role in transforming innovative designs into life-saving products. In this position, you’ll be a key player with new product development and new product introduction teams to ensure key design elements are protected and accounted for throughout the development cycle. Key Responsibilities:

• Collaborate with R&D, transfer, and manufacturing teams to ensure product excellence throughout product lifecycles
• Support regulatory submissions and audits as a product design engineer subject matter expert
• Project management across a broad range of projects and responsibilities – our team runs projects across the full breadth of product lifecycles
• Support ongoing aging testing to establish appropriate shelf life
• Develop test methods and protocols and execute testing for both new and established products
• Represent engineering in proposed engineering changes to established products
• Support corrective actions and nonconformance actions
• Interface with external test labs to support and manage required testing
• 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.
• Successfully works with new technologies and methods on new designs and upgrades to existing designs

Qualifications:

• Bachelor’s degree in biomedical engineering, mechanical engineering, manufacturing engineering or material science engineering – or another related field.
• 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.
• Desired: Experience working with medical device regulations 21 CFR 820, ISO13485, and EU MDR.

Proof of eligibility to work in the United States must be provided if selected for hire

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

Education:

• Bachelor's (Required)

Experience:

• Manufacturing Engineering: 1 year (Required)

Work Location: In person