Process Engineer - New Product Introduction

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, MasterCAM.
• Lean Manufacturing, and Process Control Concepts, Design of Experiments (DOE), Process Validation and product/process Failure Mode and Effects Analysis (FMEA).
• Use of Problem Solving and Process Improvement Methodologies (e.g. 6 Sigma, DMAIC).
• Experience with data analysis (Minitab) preferred.
• Experience with Measurement Systems (CMM's, Vision Inspection and Profilometers).
• Master's degree in engineering and/or metals/plastics machining a plus.

Additional information

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:

Benefits

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.
• #LI-LN2