ProMade New Product Development Technician

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 Research and 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:
ProMade Engineering Technician

Reports To:
Promade Product Development Manager

Location:
Austin Texas

Business Unit Description:
Driven by Enovis’ desire to create innovative products that help improve quality of life and restore movement to those suffering from degenerative arthritis, Enovis Surgical provides orthopedic surgeons with modern, patient-focused solutions for total joint arthroplasty. Enovis Surgical offers surgeons and their patients a full range of primary and revision implants for hip, knee, shoulder, and elbow reconstructive joint surgeries, in addition to the tools and digital health technology needed in today’s changing healthcare environment.

Job Title/High-Level Position Summary: The ProMade Engineering Technician provides technical, documentation, imaging-data, and product data management support for the development and lifecycle management of patient-specific orthopedic products. This position supports Product Development Engineers by performing CT segmentation refinement, managing product records, design development documentation, labeling activities, electronic design development files, and workflow execution within Agile PLM/PDM.

Key Responsibilities:

• Product Data & Configuration Management 
  • Support the part number identification process by coordinating with Product Development, Manufacturing Engineering, Packaging Engineering, Quality, Regulatory Affairs, Supply Chain, and Operations. 
  • Create and maintain approved part numbers for patient-specific implants, instruments, packaging components, and associated product records in Agile PLM/PDM. 
  • Create and maintain bills of materials, product structures, master data, and configuration records throughout the product lifecycle. 
  • Prepare and process engineering change and release documentation while maintaining configuration control and data integrity. 
• Labeling & Product Identification 
  • Support the label creation process for patient-specific products, packaging, and associated identification records. 
  • Create and maintain product label requests using released request forms and adjust as necessary through collaboration with the labeling engineer. 
• Documentation & Electronic Design File Management 
  • Create, organize, and maintain electronic Design History Files, Design Development Files, Device Master Record documentation, and other required development records. 
  • Collect, organize, and verify completion of required design control deliverables. 
  • Maintain documentation in accordance with document control, retention, and audit-readiness requirements. 
• Agile Workflow Administration 
  • Manage document routing, reviewer assignments, and approval workflows within Agile PLM/PDM. 
  • Coordinate cross-functional reviews involving Product Development, Manufacturing Engineering, Packaging Engineering, Quality, Regulatory Affairs, Supply Chain, Operations, and other required stakeholders. 
  • Monitor workflow status, communicate pending actions, escalate bottlenecks, and support timely closure of approvals. 
• Cross-Functional Project Support 
  • Participate in project meetings and provide updates on CT segmentation, part number, label, documentation, and workflow status. 
  • Support project schedules by maintaining readiness of segmentation outputs, product records, labels, design documentation, and release packages. 
  • Generate reports and metrics related to documentation status, part number creation, labeling activities, and workflow performance. 
  • Facilitate communication across functions to support timely product release activities. 
• Quality & Compliance 
  • Follow applicable quality system procedures, work instructions, data-handling requirements, and regulatory requirements. 
  • Support internal and external audits and maintain training and qualifications required for the role. 
  • Demonstrate accuracy, thoroughness, and continuous improvement in segmentation, documentation, and workflow execution. 
• CT Segmentation Refinement 
  • Perform refinement of CT image segmentations using approved software, methods, and work instructions to support patient-specific orthopedic case development. 
  • Review segmentation outputs for completeness and technical quality, document the work performed, and route outputs to the assigned ProMade Product Development Engineer for review and approval. 
  • Maintain traceability between source imaging data, refined segmentation files, derived anatomical models, and the applicable patient-specific case record. 
  • Escalate unclear anatomy, imaging artifacts, incomplete source data, or other segmentation concerns to the assigned ProMade Product Development Engineer; the technician does not make clinical interpretations or product design decisions. 
• Other Duties 
  • Perform other duties as assigned. 

Minimum Basic Qualifications:

• Associate or bachelor’s degree in Engineering Technology, Biomedical Technology, Mechanical Engineering Technology, Manufacturing Technology, Imaging Sciences, or a related discipline; or equivalent experience.
• Two or more years of experience supporting engineering, medical imaging, manufacturing, quality, document control, or regulated product development activities preferred.
• Ability to perform CT segmentation refinement using approved software and procedures; prior experience with medical image segmentation software is preferred.
• Proficiency with Microsoft Office applications.
• Experience with PLM/PDM, document control, labeling, or change management systems preferred.
• Medical device or other regulated-industry experience preferred.

Travel Requirements:

• <10%

Desired Characteristics:

• Strong attention to detail and documentation accuracy. 
• Working knowledge of CT anatomy visualization, image artifacts, and segmentation refinement techniques. 
• Excellent organization, prioritization, and follow-through. 
• Effective written and verbal communication. 
• Ability to coordinate multiple cross-functional activities and manage competing priorities. 
• Understanding of product data management, design control documentation, and quality system requirements. 
• Experience with Agile PLM/PDM or a similar product lifecycle management system preferred. 

Work Environment:

• Work may occur in office, manufacturing, warehouse, mechanical testing laboratory, or cadaver laboratory environments as required. 
• Regularly required to sit, talk, hear, and use hands to operate a computer keyboard and telephone. 
• Frequently required to stand, walk, and reach with hands and arms. 
• Occasionally required to lift or move up to 30 pounds. 
• Specific vision abilities include close vision, color vision, and the ability to adjust focus. 
• The noise level is usually moderate. 

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.

“Creating better together”. It’s the Enovis purpose, and it’s what drives us and empowers us every day on a global scale. We know that the power to create better – for our customers, our team members, and our shareholders – begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.

What does creating better together mean to us at Enovis? Discover the “why” behind our purpose, values and behaviors:

 Our Enovis Purpose, Values and Behaviors on Vimeo

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.

EQUAL EMPLOYMENT OPPORTUNITY
Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees’ beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.