Engineering Manager, Sustaining- Enabling Technologies

Who We Are
ABOUT ENOVIS™
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com.
What You'll Do
At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients, and take pride in the pursuit 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. Why work at Enovis? See for yourself.
As a key member of the Enabling Technologies 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:
Engineering Manager, Sustaining- Enabling Technologies
Reports To:
Director, R&D Product Development
Location:
Austin, TX
Business Unit:
Enabling Technology
Job Title/High Level Position Summary: The Manager, Base Business directs the sustaining engineering activities for the Enabling Technologies business unit. In addition to managing product development resources, the Manager individually contributes to development efforts. This includes but is not limited to creating prototypes, testing, and documenting test results; scheduling, coordinating, and managing multiple projects; and communicating with vendors to ensure proper design transfer. The Manager will be responsible for products including mechanical surgical instrumentation, electronic hardware, and software used by electronic hardware.
Key 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
Minimum Basic Qualifications:
Bachelor's degree in an engineering discipline
8+ years of professional experience (6+ years with a Masters degree)in a regulated industry
Experience in medical device product development
Experience with enabling technology (pre operative planning, navigation, robotics) preferred.
Familiarity with software development processes
Prior experience applying mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis.
Prior experience defining problems, collecting data, establishing facts, and drawing valid conclusions.
Prior experience interpreting an extensive variety of technical instructions in mathematical or diagram form and dealing 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.
Travel Requirements:
<5% of travel required
Desired Characteristics:
Previous experience managing engineers
Previous experience developing orthopedic medical devices(either implant development or enabling technology used with orthopedic implants)
Previous experience leading projects of moderate to large scope and complexity
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.

Skills
Excel, SolidWorks, Regulatory Affairs, Patient Care, Documentation