Sustaining Design Engineer – Medical Devices

Encore Medical LP; Austin (TX); On-site; USD 85,000 - 120,000; Full time

Job summary

Enovis is seeking a detail-oriented Sustaining Engineer to support lifecycle activities for medical devices in Austin, TX. You will handle nonconformance investigations, CAPAs, and design transfers while collaborating with Quality, Regulatory, and Manufacturing teams to ensure ongoing compliance and reliability.

The role requires a strong mechanical/biomedical engineering background, SolidWorks proficiency, and experience in regulated environments.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Biomedical, or related).
• Experience with 3D CAD software (SolidWorks strongly preferred).
• Proficiency with MS Word, Excel, and Project.
• Strong analytical and problem-solving skills.
• Ability to interpret technical data for engineering decisions.
• Experience with FDA 510(k) submissions and ISO 13485 / 21 CFR 820 knowledge is a plus.
• Experience in regulated medical devices or orthopedics preferred.
• Cross-functional collaboration across teams.

Responsibilities

• Provide sustaining engineering support for product lifecycle activities.
• Investigate nonconformances, CAPAs, and complaint handling.
• Support new product development from concept to design release.
• Create and maintain DHF documentation and risk assessments.
• Develop 3D CAD models and drawings to support changes.
• Collaborate with Quality, Regulatory, Manufacturing, and Marketing.
• Support testing, verification, and validation activities.
• Assist with design transfer and regulatory deliverables.

Skills

MS Word

MS Excel

MS Project

SolidWorks

Analytical thinking

Technical data interpretation

Education

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

Tools

SolidWorks

Job description

Enovis is seeking a detail-oriented Sustaining Engineer to support lifecycle activities for medical devices in Austin, TX. You will handle nonconformance investigations, CAPAs, and design transfers while collaborating with Quality, Regulatory, and Manufacturing teams to ensure ongoing compliance and reliability.

The role requires a strong mechanical/biomedical engineering background, SolidWorks proficiency, and experience in regulated environments.