Process Engineer - New Product Introduction

DJO Tunisie

Austin (TX)

On-site

USD 110,000 - 170,000

Full time

7 days ago
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Job summary

Enovis is a global medical technology leader based in Austin, TX, seeking a Process Engineer for New Product Introduction. You will design and transfer manufacturing processes, collaborate with cross-functional teams, and drive improvements across production lines to deliver high-quality implants and surgical instruments.

As part of the NPI Manufacturing Engineering group, you will mentor technicians, develop validation protocols, and ensure documentation meets quality systems requirements while

Qualifications

  • Bachelor's degree in science, mechanical engineering (BSME) required.
  • 10+ years in process/manufacturing engineering.

Responsibilities

  • Serve as cross-functional team member for NPI processes.
  • Assess process capabilities and drive improvements.
  • Apply technical knowledge to design and develop processes, tooling, automation.
  • Draft validation protocols and reports for new processes.
  • Lead manufacturing technical reviews.
  • Ensure documentation meets quality systems requirements.
  • Provide DFM input to design package.
  • Coach technicians and participate in lean Kaizen events.

Skills

DFM expertise
ASME Y14.5
SolidWorks CAD
Manufacturing process optimization

Education

BS in mechanical engineering

Tools

SolidWorks

Job description

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 NPI Manufacturing Engineering group 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: Process Engineer 5, New Product Introduction

Reports To: Director, Process Engineering

Location: Austin, TX

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. Partnerships with key surgeon consultants help provide advanced and proprietary patented solutions, including EMPOWR 3D Knee®, the only dual-pivot knee system on the market, and AltiVate Reverse® Shoulder, a market-leading system, based on the design principles of the RSP® Shoulder, which has demonstrated excellent clinical outcomes at 10 years. 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

As a Process Engineer NPI (New Product Introduction) you will be responsible for the design and development of new and/or improved manufacturing processes and ensuring efficient and effective design transfer of product into production. Be part of the cross functional team to lead all aspects of process development to implement manufacturing processes both within Enovis and at its suppliers. Drive improving existing manufacturing processes within the New Product Development project, which then may be shared across other production lines.

Key Responsibilities
  • Serves as a cross functional team member as primary process and manufacturing expert on new product introduction cross functional teams.
  • Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on new development projects.
  • Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
  • Executes the functional deliverables associated with the CAPA, Project Management, and Quality Systems.
  • Plans, organizes, and conducts all aspects of manufacturing technical reviews.
  • Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM's, Routers, FMEA's, etc.)
  • Writes and reviews validation protocols and reports applicable to new processes.
  • Oversees development builds associated with the project using technical work requests.
  • Provides Design for Manufacturability (DFM) input to the engineering print package.
  • Responsible for conveying the process and manufacturing limits and capabilities to the development team.
  • Contributes ideas to or generates Intellectual Property submissions.
  • May train manufacturing personnel when required as part of a validation.
  • Participate in lean reviews, and Kaizen events.
  • Coaches technicians or other engineering employees.
Minimum Basic Qualifications
  • Bachelor's degree in science, mechanical engineering (BSME), or a related engineering discipline.
  • At least 10 years of experience in a process or manufacturing engineering role.
Travel Requirements

Less than 5% travel.

Physical Requirements

Lift, carry, and pull up to 50 pounds. Stand or sit for extended periods of time.

Desired Characteristics
  • Expert-level knowledge of DFM with demonstrated ability to influence product design, establish manufacturing strategies, and optimize designs for manufacturability, quality, cost, and scalability.
  • Advanced proficiency in interpreting and applying ASME Y14.5 standards, including datum strategies, and complex dimensional requirements for precision-machined components and assemblies.
  • Expert in manufacturing processes related to orthopedic implantable products and surgical instruments.
  • Experience with CAD Software Solid Works, M
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