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About the Role
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. 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.
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
Requirements
- 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 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
- Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.
Skills
- SolidWorks
- Microsoft Word
- Microsoft Excel
- Microsoft Project
- 3D CAD modeling
- Engineering principles
- Product design
- Root cause analysis
- CAPA
- Complaint handling
- Technical report preparation
- Data analysis
Location
- Austin, TX
Work Type
- Full-time
Experience Level
- Entry Level
- Mid-Level
Education Level
- Bachelor's degree in Engineering
About the Company
- Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows.
- Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond.
Equal Opportunity
- Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law.
- We also strive to provide reasonable accommodation to employees’ beliefs and practices that do not conflict with Enovis policies and applicable law.
- We value the unique contributions that every employee brings to their role with Enovis.