Enovis

Sustaining Engineer

USA, Texas, Houston Full time

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 Foot & Ankle Research & 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:
Sustaining Engineer

Reports To:
Manager, Product Development

Location:
Houston, TX

Job Title/High-Level Position Summary:

The Sustaining Engineer 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.

Competency:

To perform the job successfully, an individual should demonstrate the following competencies:

  • Analytical - Synthesizes complex or diverse information.
  • Design - Demonstrates attention to detail.
  • Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; uses reason even when dealing with emotional topics.
  • Project Management - Communicates changes and progress.
  • Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills.
  • Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification.
  • Written Communication - Writes clearly and informatively; varies writing style to meet needs; able to read and interpret written information. Writes detailed test protocols/reports.
  • Quality Management - Looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
  • Business Acumen - Understands business implications of decisions.
  • Diversity - Shows respect and sensitivity for cultural differences; promotes a harassment-free environment.
  • Judgment - Exhibits sound and accurate judgment; includes appropriate people in decision-making process.
  • Safety and Security - Observes safety and security procedures; reports potentially unsafe conditions; uses equipment and materials properly.       
  • Demonstrates commitment to the Enovis Compliance & Ethics Program, the Enovis Code of Conduct, the Enovis Sales and Marketing Code of Conduct, the AdvaMed Code of Ethics, and all supporting and applicable regulations, policies and procedures.
  • Demonstrates commitment to the Enovis Values, Mission and Vision.

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.

Minimum Basic Qualifications:

  • Bachelor's degree in an engineering discipline
  • Experience in medical devices and/or orthopedics preferred.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Prepare product reports by collecting, analyzing, and summarizing information and trends.
  • Assist in the 510(k) application process by providing official test batch and qualification information for FDA review
  • Must be experienced in MS Word, Excel and Project.
  • Experience with 3D CAD packages (SolidWorks preferred)

Work Environment / Physical Demands:

  • Climate controlled workspace
  • Typical warehouse environment, including the ability to lift up to 25 lbs.
  • Physical Demands: standing, sitting, climbing, crouching/kneeling, lifting, carting, etc.

“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.

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.