Development Engineer, Base Business

Enovis • Austin, TX

2d • Onsite

About The Position

Enovis Corporation is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. As a key member of the Engineering / Quality / Sustaining Operations team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. We are seeking a detail-oriented and technically strong Sustaining Engineer to support ongoing product lifecycle activities, ensuring the performance, quality, and compliance of existing medical devices. This role is responsible for providing engineering support across quality, manufacturing, and regulatory functions, including investigation of nonconformances, complaints, and corrective actions. The Sustaining Engineer will also contribute to product improvement initiatives and support new product development and design transfer activities. This role works closely with cross-functional teams including Quality Assurance, Regulatory Affairs, Manufacturing, Product Development, and Marketing to ensure continued product reliability and compliance with regulatory standards. The ideal candidate has strong mechanical design and documentation skills, experience in regulated environments, and a passion for improving medical device performance and reliability.

Requirements

• Bachelor’s degree in Engineering (Mechanical, Biomedical, or related discipline) required
• 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

Nice To Haves

• Experience in medical device or other highly regulated industries preferred
• Experience supporting FDA 510(k) submissions and providing technical test documentation preferred
• Working knowledge of ISO 13485 and 21 CFR 820
• Experience in orthopedics or surgical instrumentation preferred
• Experience in root cause analysis, CAPA, and complaint handling
• Strong ability to define problems, analyze data, and develop actionable conclusions
• Experience preparing technical reports and summarizing engineering trends

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

Benefits

• Enovis does not provide sponsorship for employment visas (e.g., H-1B) and will not offer such sponsorship in the future. Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level