NPI Quality Engineer, Medical Devices

DJO Tunisie; Houston (TX); On-site; USD 87,000 - 104,000; Full time

Benefits offered by this job

Annual performance bonus

Job summary

Enovis is seeking an NPI Quality Engineer in Houston, TX. You will contribute to design reviews, risk analysis, and development of quality systems for new product introductions in the Foot & Ankle unit. The role requires a biomedical or mechanical engineering background and strong regulatory knowledge.

You will lead quality activities for NPD and sustaining projects, manage CAPAs, and support FDA/ISO audits, with up to 20% travel. Competitive base pay and annual bonus are offered.

Qualifications

• Bachelor's degree in Biomedical or Mechanical Engineering (or equivalent).
• 5+ years in medical device quality/controls roles.
• Experience with ISO13485, GMP, FDA audits.
• Strong technical writing and documentation skills.

Responsibilities

• Participate in design and manufacturing reviews.
• Generate DFMEAs/UFMEAs and contribute to risk analysis.
• Develop inspection strategies for new products.

Skills

Regulatory awareness

Technical writing

Cross-functional collaboration

Attention to detail

Problem solving

Education

Bachelor's degree in Biomedical or Mechanical Engineering

CQE Certification

Lean Six Sigma / 6 Sigma Certification

Tools

Solidworks

Solidworks ePDM

MiniTab

Netsuite

Agile PLM

CMM programming

Microsoft Office

Job description

Enovis is seeking an NPI Quality Engineer in Houston, TX. You will contribute to design reviews, risk analysis, and development of quality systems for new product introductions in the Foot & Ankle unit. The role requires a biomedical or mechanical engineering background and strong regulatory knowledge.

You will lead quality activities for NPD and sustaining projects, manage CAPAs, and support FDA/ISO audits, with up to 20% travel. Competitive base pay and annual bonus are offered.