Development Engineer, Base Business

ABOUT ENOVIS

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 Companys extensive range of products services and integrated technologies fuels active lifestyles in orthopedics and more information about Enovis please visit .

What Youll Do

At Enovis we pay attention to the details. We embrace collaboration with our partners and patients and take pride in the pursuit of scientific excellence with the goal of transforming medical technology as we know it.
Because thats how we change the lives of patients for the better. And thats how we create better together. Why work at Enovis See for yourself.

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.

Job Title:

Development Engineer Base Business

Reports To:

Sr Director R&D Product Development

Location:

Austin TX

Job Title/High Level Position Summary:

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.

Key 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 theproduct lifecycle
Support verification and validation activities including test planning execution and reporting

Scope / Role Dimensions

Supports both sustaining engineering and new product development lifecycle activities
Works cross-functionally across engineering quality manufacturing and regulatory teams
Contributes to design control documentation and regulatory compliance deliverables
Supports both internal manufacturing and supplier transfer activities

Minimum Qualifications

Bachelors 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

Desired Qualifications

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

Core Competencies

Technical Expertise: Strong understanding of product design CAD modeling and engineering principles
Regulatory & Quality Awareness: Ensures compliance with medical device standards and procedures
Problem Solving: Effectively investigates and resolves product and process issues
Collaboration: Works seamlessly across cross-functional teams
Documentation Excellence: Maintains high-quality engineering and regulatory documentation
Continuous Improvement: Identifies opportunities to enhance product performance and reliability

Working Conditions

Exposure to office manufacturing and laboratory environments
May include mechanical testing labs and cadaver lab environments
Occasional travel outside the Houston metropolitan area (typically monthly or bi-monthly)
Moderate noise levels depending on work location
Requires ability to work in both seated computer-based tasks and hands-on environments

Physical Requirements

Ability to sit stand walk and use hands for extended periods
Ability to operate computer and standard office equipment
Occasional lifting of up to 40 lbs
Ability to work full-time (8 hours per day) in varied environments

Who Were Looking For:

Detail-Oriented Engineer ensures accuracy in documentation design and analysis
Collaborative Problem Solver works across teams to resolve product issues effectively
Quality-Focused Professional committed to maintaining compliance and product reliability
Hands-On Technical Contributor comfortable working in both office and lab environments
Continuous Improver driven to enhance product performance and lifecycle outcomes
Reliable Partner supports critical sustaining and regulatory engineering activities

Currently 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.

EQUAL EMPLOYMENT 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.