Medical Device Process Engineering Manager – Austin

Key People; Austin (TX); On-site; USD 150,000 - 160,000; Full time

Job summary

Key People in Austin, TX is seeking a Manager, Process Engineering to lead onsite manufacturing engineering efforts. You will oversee a skilled team, drive design transfer and process development, and ensure manufacturing readiness across multiple product lines.

This player-coach role requires mentoring engineers, owning CAPA and quality-system deliverables, and collaborating with cross-functional teams to maintain strict regulatory standards and continuous improvement.

Qualifications

• Bachelor's degree in mechanical engineering or a related field.
• 10+ years in process or manufacturing engineering.
• 3+ years managing an engineering team.
• Machining background.
• New product introduction experience.
• Hands-on experience with CMMs, vision inspection systems and profilometers.
• Strong GD&T.
• Data analysis and statistics (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.
• Provide design for manufacturability (DFM) 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.
• Make sure 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.
• Take part in lean reviews and Kaizen events, and contribute to intellectual property submissions.

Skills

Process engineering

Team leadership

Manufacturing execution

Education

Bachelor's degree in mechanical engineering

Tools

CMMs

Vision inspection systems

Profilometers

Job description

Key People in Austin, TX is seeking a Manager, Process Engineering to lead onsite manufacturing engineering efforts. You will oversee a skilled team, drive design transfer and process development, and ensure manufacturing readiness across multiple product lines.

This player-coach role requires mentoring engineers, owning CAPA and quality-system deliverables, and collaborating with cross-functional teams to maintain strict regulatory standards and continuous improvement.