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.
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
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