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: •
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.
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.
