Development Engineer II, Base Business

Enovis; Austin (TX); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Spending and Savings Accounts

401(k) Plan

Vacation, Sick Leave, and Holidays

Income Protection Plans

Discounted Insurance Rates

Legal Services

Job summary

Enovis in Austin, TX is seeking a Product Development Engineer to design, test, and contribute to development activities for medical device products. You will interface with physicians and customers to determine needs, create prototypes, test results, and document outcomes.

The role involves scheduling, coordinating, and managing multiple projects, and communicating with vendors to ensure product quality. You will work on mechanical instrumentation, electronic hardware, and related software.

Qualifications

• Bachelor's degree in an engineering discipline.
• 2+ years of professional experience (1 year with a Masters).
• Ability to apply mathematical operations and analyze data.
• Ability to define problems, collect data, and draw conclusions.
• Experience with 3D CAD (SolidWorks preferred) and documentation.
• Proficiency in MS Word, Excel and Project.

Responsibilities

• Participate in product development from concept to design and metrics.
• Provide detailed design output and manage project delays and resources.
• Create design documentation, risk assessments, and validation plans.
• Develop engineering drawings using 3‑D modeling (SolidWorks).
• Collaborate with cross‑functional teams to define tasks and requirements.
• Maintain Design History File documentation and aid FDA 510(k) submissions.

Skills

Analytical thinking

Problem solving

Communication

Cross-functional collaboration

Project coordination

Education

Bachelor's degree in engineering

Tools

SolidWorks

MS Word

Excel

MS Project

Job description

Who We Are

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.

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 Enabling Technologies 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

Product Development Engineer

Reports To

Manager, Base Business-Enabling Technologies

Location

Austin, TX

Business Unit Description

Enabling Technologies

Job Title/High Level Position Summary

The Product Development Engineer will design, test, and participate in development activities for company products. This includes but is not limited to interfacing with physicians and other customers to determine needs/requirements; creating prototypes, testing, and documenting test results; scheduling, coordinating, and managing multiple projects; and communicating with vendors to ensure product quality. The Product Development Engineer will be responsible for products including mechanical surgical instrumentation, electronic hardware, and software used by electronic hardware.

Key Responsibilities

• Participate in product development including concept, generation, decision matrices, prototype, manufacture, and associated metrics


• Provide detailed design and development output for the development projects assigned; this includes unrelenting attention to minimizing project delays and resource overages


• Creates product designs and documentation used to substantiate those devices (i.e. risk assessments, verification/validation activities, design review documentation, etc.)


• Develops detailed engineering drawings using 3‑D Modeling to document designs and design changes (SolidWorks)


• Confers with cross‑functional team to identify tasks and requirements (Product Development, Manufacturing Engineers, Quality Engineers, Marketing, Purchasing and Regulatory Affairs)


• Maintains all documentation necessary for a Design History File (DHF), including Design Input Documents, Design Validation Plans/Reports, Test Protocols/Reports, and Design Input/Output Matrix.


• Assist in the 510(k) application process by providing official information for FDA review

Minimum Basic Qualifications

• Bachelor's degree in an engineering discipline


• 2+ years of professional experience (1 year with a Masters degree)


• Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis.


• Ability to define problems, collect data, establish facts, and draw valid conclusions.


• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.


• Must be experienced in MS Word, Excel and Project.


• Experience with 3D CAD packages (SolidWorks preferred)

Travel Requirements

• <5% of travel required

Desired Characteristics

• Experience in medical devices and/or orthopedics


• Familiarity with software development processes


• Working knowledge and requirements of ISO 13485 and 21CFR820.

Work Environment

• While performing the duties of this job, the employee is exposed to the manufacturing environment.


• While performing the duties of this job, the employee is exposed to the office environment.


• Employee is expected to work in varying environments, including office setting, mechanical testing lab, and cadaver lab.


• The noise level in the work environment is usually moderate.

Physical Demands

• While performing the duties of this job, the employee is regularly required to sit, talk and hear.


• The employee frequently is required to sit and use hands to operate computer keyboard, and telephone.


• The employee is frequently required to stand, walk, and reach with hands and arms.


• This position works in a typical office/manufacturing/warehouse environment.


• The employee must occasionally lift and/or move up to 30 pounds.


• Perform job duties for 8 or more hours a day.

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.

"Creating better together". It's the Enovis purpose, and it's what drives us and empowers us every day on a global scale.

What does creating better together mean to us at Enovis? Discover the "why" behind our purpose, values and behaviors:

Our Enovis Purpose, Values and Behaviors on Vimeo

We offer a comprehensive benefits package that includes:

• Medical Insurance


• Dental Insurance


• Vision Insurance


• Spending and Savings Accounts


• 401(k) Plan


• Vacation, Sick Leave, and Holidays


• Income Protection Plans


• Discounted Insurance Rates


• Legal Services

Join us in creating better together.

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.