Process Engineering Manager | Medical Devices & NPI Lead

Top Echelon Software, LLC.; Austin (TX); On-site; USD 150,000 - 160,000; Full time

Job summary

Top Echelon Software, LLC. in Austin, TX seeks a Manager of Process Engineering to lead a seasoned team through transfer of new products to production, partner with cross-functional teams, and champion process improvements. Expect hands-on mentorship, strong GD&T, and a focus on DFx and CAPA within a regulated environment.

The role emphasizes design transfer, tooling and automation development, and collaboration with design and supplier teams to ensure robust manufacturing processes.

Qualifications

• 10+ years in process or manufacturing engineering
• 3+ years managing an engineering team
• Bachelor's degree in mechanical engineering or related field
• Machining background
• New product introduction experience
• Hands-on experience with CMMs, vision inspection systems and profilometers
• Strong GD&T
• Data analysis and statistics skills (Minitab preferred)
• Risk assessment experience (FMEA)

Responsibilities

• Lead, coach and develop manufacturing engineers and technicians
• Serve as the primary process and manufacturing expert on cross-functional new product teams
• Drive design transfer of new products into production, both in-house and at suppliers
• Give design for manufacturability input on engineering prints and communicate process limits and capabilities to design teams
• Guide process capability assessments and prioritize and implement process improvements
• Design and develop processes, tooling, fixturing and automation
• Write and review process validation protocols and reports
• Ensure documentation meets quality system requirements (BOMs, routers, FMEAs)
• Own deliverables tied to CAPA, project management and quality systems
• Plan and lead manufacturing technical reviews and oversee development builds
• Participate in lean reviews and Kaizen events, and contribute to IP submissions

Skills

Process engineering

Manufacturing engineering

Engineering leadership

Machining background

New product introduction

CMMs / vision systems / profilometers

GD&T

Minitab data analysis

FMEA risk assessment

Education

Bachelor's degree in Mechanical Engineering

Master's degree in Engineering

Tools

CMMs

Vision inspection systems

Profilometers

Job description

Top Echelon Software, LLC. in Austin, TX seeks a Manager of Process Engineering to lead a seasoned team through transfer of new products to production, partner with cross-functional teams, and champion process improvements. Expect hands-on mentorship, strong GD&T, and a focus on DFx and CAPA within a regulated environment.

The role emphasizes design transfer, tooling and automation development, and collaboration with design and supplier teams to ensure robust manufacturing processes.