Principal Quality Engineer - Med Device Leader

Cedarparktexasedc; Austin (TX); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Paid Time Off

Job summary

Enovis in Austin, TX is seeking a Principal Quality Engineer to provide technical leadership across NPD and sustaining engineering, ensuring product quality and regulatory compliance throughout the lifecycle.

The role requires expert knowledge of FDA QSR and ISO 13485, plus strong problem-solving, vendor collaboration, and mentorship of junior engineers. This on-site position offers comprehensive benefits and opportunities to influence quality culture at Enovis.

Qualifications

• BS in a technical field aligned with medical device quality systems.
• Experience with FDA QSR (21 CFR Part 820) and ISO 13485.
• Experience supporting new product development with Design Controls.
• Strong writing, analytical, and problem-solving skills.

Responsibilities

• Serve as senior QA representative for NPD and sustaining projects.
• Lead design reviews to ensure QMS and regulatory compliance.
• Lead risk management activities including DFMEAs/PFMEAs.
• Review and approve design controls, inputs, outputs, and validation docs.
• Support internal/external audits (FDA, ISO 13485, MDSAP).
• Drive continuous improvement using Lean, Six Sigma concepts.
• Mentor junior QA engineers and cross-functional teams.

Skills

Quality Assurance

Regulatory compliance

Project leadership

Communication skills

Risk management

Software verification & validation

Education

Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or related technical discipline

Tools

PLM (e.g., Agile PLM)

ERP systems (Oracle, SAP, Windchill)

Job description

Enovis in Austin, TX is seeking a Principal Quality Engineer to provide technical leadership across NPD and sustaining engineering, ensuring product quality and regulatory compliance throughout the lifecycle.

The role requires expert knowledge of FDA QSR and ISO 13485, plus strong problem-solving, vendor collaboration, and mentorship of junior engineers. This on-site position offers comprehensive benefits and opportunities to influence quality culture at Enovis.