Enabling Technologies Manager - Medical Devices & Prototyping

Enovis; Austin (TX); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

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

Job summary

Enovis in Austin, TX is seeking a Manager, Base Business - Enabling Technologies to lead sustaining engineering for the Enabling Technologies unit. You will drive prototypes, testing, design transfer, and cross-functional collaboration with manufacturing, quality, and regulatory teams.

The role combines hands-on engineering with project leadership, documentation, and risk assessment activity, including design history files, verification plans, and regulatory support, to deliver robust medical

Qualifications

• Bachelor’s degree in an engineering discipline.
• 8+ years of professional experience (6+ years with a Masters degree).
• Experience in medical device product development.
• Experience with enabling technology (pre operative planning, navigation, robotics) preferred.
• Familiarity with software development processes.
• 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)
• Working knowledge and requirements of ISO 13485 and 21CFR820.

Responsibilities

• Manage project prioritization and resource allocation
• Mentor direct reports by providing technical guidance, coaching, performance management, and professional development opportunities
• Participate in product development including concept, generation, decision matrices, prototype, manufacture, and associated metrics
• Provide expert product leadership for the development projects assigned; this includes an 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 regulatory submission process(FDA 510k, EU MDR, TGA, PMDA) by providing official information for regulatory review

Skills

Project management

3D CAD

Regulatory knowledge

MS Office

Engineering leadership

Documentation

Education

Bachelor’s degree in engineering

Master’s degree in engineering

Tools

SolidWorks

Job description

Enovis in Austin, TX is seeking a Manager, Base Business - Enabling Technologies to lead sustaining engineering for the Enabling Technologies unit. You will drive prototypes, testing, design transfer, and cross-functional collaboration with manufacturing, quality, and regulatory teams.

The role combines hands-on engineering with project leadership, documentation, and risk assessment activity, including design history files, verification plans, and regulatory support, to deliver robust medical