Sustaining Engineer

Job Description:

At Enovis we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind 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.

As a key member of the Product Development 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:

Associate Product Development Engineer, Sustaining

Reports To:

Manager, Product Engineering

Location:

Houston, TX

Business Unit Description:

Enovis Foot & Ankle

Job Title/High Level Position Summary: The Associate/Sr. Associate/or Product Development Engineer, Sustaining will primarily be responsible for providing technical support to RA/QA/MFG for NCMR, CAPA/HHE, validations and complaint investigations. Additionally, the sustaining engineer will own sustaining/product improvement projects and provide support to upper-level engineers in all aspects of new product development projects from proposal to final design/release, including design transfer support (internal and supplier transfer).The engineer will work with a cross-functional product team consisting of upper-level product development engineers, marketing product managers, manufacturing engineers, regulatory and QA engineers in the design, development, and design transfer of surgical instruments and implants.

Key Responsibilities:

• Supports various sustaining engineering projects including line extensions and supplier/internal manufacturing transfer projects
• Supports new product development projects from proposal to final design/release
• 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.
• Provides technical support and review for Non-Conforming Material Reports and product complaint investigations.
• Provides technical support and review for Corrective and Preventative Actions and Health Hazard Evaluations.

Minimum Basic Qualifications:

• Bachelor's degree in an engineering discipline
• Experience in medical devices and/or orthopedics preferred.
• Must be experienced in MS Word, Excel and Project.
• Prior experience with 3D CAD packages (SolidWorks preferred)

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

Travel Requirements:

• Ability to travel via automobile and/or airplane as needed (travel out of the Houston metropolitan area will be needed) - Typically once a month or once every two months

Desired Characteristics:

• Prior experience assisting in the 510(k) application process by providing official test batch and qualification information for FDA review
• Previous experience in a regulated environment, Medical Device, Aeronautics, Automotive or other highly regulated industry required
• Working knowledge and requirements of ISO 13485 and 21CFR820.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Prepare product reports by collecting, analyzing, and summarizing information and trends.

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

"Creating better together". It's the Enovis purpose, and it's what drives us and empowers us every day on a global scale. We know that the power to create better - for our customers, our team members, and our shareholders - begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.

Watch this short on creating the next generation of better together at Enovis:

Better is... | Enovis

We offer a comprehensive benefits package which 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

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. Visit www.enovis.com to learn more.

EQUAL EMPLOYMENT OPPORTUNITY:

Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and 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.

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.

EOE AA M/F/VET/Disability Statement

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.