Associate Principal Engineer

Responsibilities

• Lead multidisciplinary technical teams in the design, development, and manufacturing of dental and medical instrumentation.
• Manage mid-scale projects and provide technical leadership for the new product development process.
• Own process ownership for production and assembly operations, implementing improvements based on KPIs.
• Manage Design History Files (DHF) and maintain design control processes including DMR and Technical Files.
• Research and implement new technologies, materials, and automation solutions to improve efficiency and cost-effectiveness.
• Design and execute validation protocols (IQ, OQ, PQ) and ensure compliance with 21 CFR Part 11.
• Provide coaching and mentorship to junior engineers.

Requirements

• Bachelor's or Master's degree in Engineering (Mechanical, Chemical, Physics, or Computer Science).
• 5+ years of experience in medical or dental device manufacturing.
• Advanced knowledge of FDA regulatory requirements and GMP quality standards.
• Proven experience executing Six Sigma and Lean Manufacturing projects.
• Strong proficiency in new product development processes from concept through full production release.
• Experience managing large-scale projects within a manufacturing environment, including budget management.

Preferred Qualifications

• Industry-specific certifications.
• Experience with 3-D parametric modeling software.
• Experience with software integration, APIs, and manufacturing systems (ERP, MES).

Benefits

• Medical, Dental, and Vision coverage.
• 401K Plan with company match.
• Generous time off and paid parental leave.
• Educational benefits and worldwide scholarship programs.
• Income protection and work-life assistance programs.

About the Company

Brasseler USA is a world-class healthcare organization known for providing high-quality, clinician-endorsed, and innovative dental and medical instrumentation. With a reputation spanning over 40 years, we are dedicated to quality products sold with integrity and a culture that values diverse perspectives and professional development.