Development Engineer, Base Business
About The Position
Enovis Corporation is an innovation-driven medical technology growth company focused on developing clinically differentiated solutions that improve patient outcomes and transform workflows. The company fosters a culture of continuous improvement, global talent, and innovation. This role is a key member of the Engineering / Quality / Sustaining Operations team, contributing to advancing medical technology, transforming patient care, and achieving better patient outcomes. The Sustaining Engineer will support ongoing product lifecycle activities, ensuring the performance, quality, and compliance of existing medical devices. Responsibilities include engineering support for quality, manufacturing, and regulatory functions, investigating nonconformances, complaints, and corrective actions, contributing to product improvement initiatives, and supporting new product development and design transfer. The role requires close collaboration with cross-functional teams such as Quality Assurance, Regulatory Affairs, Manufacturing, Product Development, and Marketing to ensure product reliability and regulatory compliance. The ideal candidate possesses strong mechanical design and documentation skills, experience in regulated environments, and a passion for enhancing 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
