Development Engineer, Base Business

Enovis; Austin (TX); On-site; USD 85,000 - 120,000; Full time

Job summary

Enovis in Austin, TX seeks a detail‑oriented Sustaining Engineer to support product lifecycle activities, ensuring performance, quality, and regulatory compliance of existing medical devices. You will provide engineering support across quality, manufacturing and regulatory functions, including investigations of nonconformances and CAPA.

The role involves collaborating with cross‑functional teams to drive design changes, maintain DHF documentation, and support new product development and design

Qualifications

• 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 knowledge of ISO 13485 and 21 CFR 820 is a plus.

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.

Skills

Analytical skills

Problem solving

Documentation

Collaboration

Regulatory understanding

Education

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

Tools

SolidWorks

Microsoft Word

Microsoft Excel

MS Project

Job description

Who We Are

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 Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond.For more information about Enovis, please visit www.enovis.com.

What You'll 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 that's how we change the lives of patients for the better. And that's 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

• 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

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 We're 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.