Sustaining Engineer - Medical Devices (CAD/Regulatory)

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

Job summary

Enovis in Austin, TX seeks a detail‑oriented Sustaining Engineer to support product lifecycle activities, ensuring performance, quality, and regulatory compliance of existing medical devices. You will provide engineering support across quality, manufacturing and regulatory functions, including investigations of nonconformances and CAPA.

The role involves collaborating with cross‑functional teams to drive design changes, maintain DHF documentation, and support new product development and design

Qualifications

• Bachelor's degree in Engineering (Mechanical, Biomedical, or related discipline) required.
• Experience in medical device or other highly regulated industries preferred.
• Proficiency in Microsoft Word, Excel, and Project.
• Experience with 3D CAD software (SolidWorks strongly preferred).
• Strong analytical and problem-solving skills.
• Ability to interpret technical data and support engineering decision-making.
• Experience supporting FDA 510(k) submissions and knowledge of ISO 13485 and 21 CFR 820 is a plus.

Responsibilities

• Provide engineering support for Non-Conforming Material Reports (NCMR), CAPA investigations, complaint handling, and Health Hazard Evaluations (HHE).
• Support sustaining engineering projects, including line extensions and internal/supplier manufacturing transfers.
• Support new product development projects from concept through final design release and design transfer.
• Create and maintain engineering documentation supporting the Design History File (DHF), including design inputs/outputs, risk assessments, verification and validation documentation, and design review records.
• Develop and update detailed 3D CAD models and engineering drawings (SolidWorks) to support design changes and product improvements.
• Collaborate with cross-functional teams including Product Development, Manufacturing, Quality, Regulatory, Purchasing, and Marketing to define requirements and execute projects.
• Provide technical input and support for complaint investigations and failure analysis.
• Support CAPA investigations with data analysis, root cause identification, and corrective action implementation.
• Ensure compliance with internal quality systems and external regulatory requirements throughout the product lifecycle.
• Support verification and validation activities, including test planning, execution, and reporting.

Skills

Analytical skills

Problem solving

Documentation

Collaboration

Regulatory understanding

Education

Bachelor's degree in Engineering (Mechanical, Biomedical, or related discipline)

Tools

SolidWorks

Microsoft Word

Microsoft Excel

MS Project

Job description

Enovis in Austin, TX seeks a detail‑oriented Sustaining Engineer to support product lifecycle activities, ensuring performance, quality, and regulatory compliance of existing medical devices. You will provide engineering support across quality, manufacturing and regulatory functions, including investigations of nonconformances and CAPA.

The role involves collaborating with cross‑functional teams to drive design changes, maintain DHF documentation, and support new product development and design