Senior Process Engineering Lead, Medical Devices – Austin

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 manufacturing process team and drive products from design to production.

This player-coach role requires hands-on leadership, DFM input, and cross-functional collaboration on development projects within a regulated medical device setting. Expect lean improvements and strong quality system involvement.

Qualifications

• Bachelor's degree in mechanical engineering or related field.
• 10+ years in process or manufacturing engineering.
• 3+ years managing an engineering team.
• Machining background.
• New product introduction experience.
• Hands-on 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 prints and communicate process limits.
• Guide process capability assessments and implement 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 development builds.
• Participate in lean reviews, Kaizen events, and IP submissions.

Skills

10+ years in process or manufacturing

3+ years managing an engineering team

Machining background

New product introduction experience

Hands-on with CMMs, vision inspection,

GD&T

Data analysis & statistics (Minitab)

FMEA risk assessment

Education

Bachelor's degree in mechanical engineering or related field

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 manufacturing process team and drive products from design to production.

This player-coach role requires hands-on leadership, DFM input, and cross-functional collaboration on development projects within a regulated medical device setting. Expect lean improvements and strong quality system involvement.