Engineering Manager, Enabling Technologies

Enovis Corporation; Austin, Northern (TX, KY); Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Paid Vacation

Sick Leave

Holidays

Income Protection Plans

Discounted Insurance Rates

Job summary

Enovis Corporation in Austin, TX seeks a Manager, Base Business - Enabling Technologies to direct sustaining engineering for the Enabling Technologies unit. You will manage development resources, create prototypes, test, document results, and coordinate multi-project execution across hardware and software domains.

The role requires a strong engineering background, leadership, and hands-on design and documentation skills, with exposure to ISO 13485 and 21CFR820.

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.
• 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 minimizing project delays and resource overages.
• Create product designs and documentation used to substantiate devices (risk assessments, verification/validation activities, design review documentation, etc.).
• Develop detailed engineering drawings using 3-D Modeling to document designs and 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 for 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).

Skills

Experience in medical device product,

Enabling technology experience

Familiarity with software development

Mathematical analysis

Leadership / mentoring

Education

Bachelor's degree in engineering

Tools

SolidWorks

MS Word

Excel

MS Project

Job description

Enovis Corporation in Austin, TX seeks a Manager, Base Business - Enabling Technologies to direct sustaining engineering for the Enabling Technologies unit. You will manage development resources, create prototypes, test, document results, and coordinate multi-project execution across hardware and software domains.

The role requires a strong engineering background, leadership, and hands-on design and documentation skills, with exposure to ISO 13485 and 21CFR820.