Process Engineer II - Medical Device Manufacturing

Austin, Inc.; Austin (TX); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision

Life Insurance

401(k) with Traditional and Roth

ESPP

Paid Holidays

PTO

Tuition Reimbursement

Job summary

Artivion, Inc. in Austin is seeking a Process Engineer to provide engineering support for the Machine Shop within an FDA/ISO-regulated manufacturing environment.

You will drive process improvements, develop SOPs and work instructions, and collaborate with quality and R&D to sustain production and support new product launches. Responsibilities include leading IQ/OQ/PQ validations, PFMEA, CAPA resolution, and CAD/drawing updates.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Chemical, Biomedical, Industrial or related field).
• 2–5 years in medical device or related engineering experience (1–3 years with Masters).
• Data-driven problem solving with SPC and root-cause analysis.
• Lean manufacturing / process optimization experience.
• Cross-functional collaboration with operators, quality, regulatory and management.

Responsibilities

• Own manufacturing processes in FDA/ISO environment, ensuring stability and compliance.
• Troubleshoot processes/equipment, perform root-cause analysis, and train production teams.
• Develop and maintain SOPs, work instructions, drawings, and audit readiness.
• Lead IQ/OQ/PQ validations, PFMEA, and risk management activities.
• Coordinate with Quality to resolve nonconformances and drive CAPA.

Skills

Data-Driven Problem Solving

Process Optimization / Lean Mfg.

Cross-Functional Collaboration

Education

Bachelor's degree in Engineering

Tools

CAD/CAM & Programming Proficiency

CNC / Machining Knowledge

Job description

Artivion, Inc. in Austin is seeking a Process Engineer to provide engineering support for the Machine Shop within an FDA/ISO-regulated manufacturing environment.

You will drive process improvements, develop SOPs and work instructions, and collaborate with quality and R&D to sustain production and support new product launches. Responsibilities include leading IQ/OQ/PQ validations, PFMEA, CAPA resolution, and CAD/drawing updates.