Senior Process Engineering Lead — Medical Devices

MDS Staffing; Austin (TX); On-site; USD 150,000 - 160,000; Full time

Job summary

MDS Staffing is seeking a Manager of Process Engineering in Austin, TX onsite. You will lead a sizable team of engineers and technicians, driving new product introductions from design into production and ensuring quality and compliance across multiple product lines.

You will provide design for manufacturability input, guide process validation, and own CAPA and documentation in a fast-paced medical device environment. Relocation assistance is available.

Qualifications

• 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 skills (Minitab preferred)
• Risk assessment experience (FMEA)

Responsibilities

• Lead, coach and develop manufacturing engineers and technicians
• Serve as 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 DFMs input on engineering prints and communicate process limits and capabilities
• Guide process capability assessments 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; contribute to IP submissions

Skills

Process engineering

Manufacturing engineering

Team management

New product introduction

Lean manufacturing

DOE

FMEA

Minitab

CMMs

Vision inspection

Profilometers

Education

Bachelor's degree in mechanical engineering or related field

Tools

CMMs

Vision inspection systems

Profilometers

SolidWorks

Mastercam

Minitab

Job description

MDS Staffing is seeking a Manager of Process Engineering in Austin, TX onsite. You will lead a sizable team of engineers and technicians, driving new product introductions from design into production and ensuring quality and compliance across multiple product lines.

You will provide design for manufacturability input, guide process validation, and own CAPA and documentation in a fast-paced medical device environment. Relocation assistance is available.