Associate Product Development Engineer, Sustaining

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

• 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.

• 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)

• 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

• 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.

• 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.

• 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.

• 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