Senior Process Engineering Manager – Medical Devices

Zaddy Solutions; Austin (TX); On-site; USD 150,000 - 160,000; Full time

Job summary

Zaddy Solutions in Austin, TX is seeking a Manager of Process Engineering to lead a team of engineers and technicians onsite. You will guide cross-functional product development, drive design transfer to production, and ensure robust process capability with DFx input on designs.

You will own process validation, CAPA deliverables, and quality system documentation while shaping continuous improvement initiatives across multiple product lines.

Qualifications

• Bachelor's degree in mechanical engineering or a related field is required.
• 10+ years of process or manufacturing engineering experience.
• Minimum 3 years of engineering leadership experience.

Responsibilities

• Lead, coach and develop manufacturing engineers and technicians.
• Serve as primary process and manufacturing expert on cross-functional teams.
• Drive design transfer of new products into production.
• Provide DFm input on engineering prints and communicate capabilities.
• 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 develop builds.

Skills

10+ years in process/manufacturing eng

3+ years engineering team management

Machining background

New product introduction

CMMs

Vision inspection systems

Profilometers

GD&T

Data analysis (Minitab)

FMEA

Education

Bachelor's degree in mechanical engineering or related field

Tools

SolidWorks

Mastercam

Job description

Zaddy Solutions in Austin, TX is seeking a Manager of Process Engineering to lead a team of engineers and technicians onsite. You will guide cross-functional product development, drive design transfer to production, and ensure robust process capability with DFx input on designs.

You will own process validation, CAPA deliverables, and quality system documentation while shaping continuous improvement initiatives across multiple product lines.