Senior Process Engineering Lead – Medical Devices

LRSolutions, LLC; Austin (TX); On-site; USD 150,000 - 160,000; Full time

Job summary

LRSolutions, LLC, a growing medical device manufacturer in Austin, TX, seeks a Manager, Process Engineering to lead the process engineering team from design into production. You will guide engineers and technicians, participate in cross-functional development teams, and drive design transfer to manufacturing both in-house and with suppliers.

You will own process validation, CAPA alignment, and documentation while advancing lean initiatives, process improvements, and IP contributions.

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 experience with CMMs, vision inspection systems and profilometers.
• Strong GD&T knowledge.
• 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 teams.
• Drive design transfer of new products into production, in-house and with suppliers.
• Provide DFMs input on engineering 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 and Kaizen events; contribute to IP submissions.

Skills

Process engineering

Data analysis

FMEA

GD&T

NPI experience

Education

Bachelor's degree in mechanical engineering

Master's degree in engineering (nice to have)

Tools

CMMs

Vision inspection systems

Profilometers

Job description

LRSolutions, LLC, a growing medical device manufacturer in Austin, TX, seeks a Manager, Process Engineering to lead the process engineering team from design into production. You will guide engineers and technicians, participate in cross-functional development teams, and drive design transfer to manufacturing both in-house and with suppliers.

You will own process validation, CAPA alignment, and documentation while advancing lean initiatives, process improvements, and IP contributions.