Process Engineer - New Product Introduction

Enovis•Austin, TX

About The Position

The Process Engineer, New Product Introduction, is part of Enovis Surgical’s NPI Manufacturing Engineering group. The role designs and develops new or improved manufacturing processes and supports efficient, effective transfer of products into production. As a cross-functional team member and primary process and manufacturing expert, the engineer leads process development and implementation at Enovis and its suppliers, improves manufacturing processes within product development projects, and may help share improvements across production lines. The position reports to the Director, Process Engineering and is located in Austin, Texas. Enovis Surgical develops orthopedic solutions, including implants, instruments, and digital health technology for reconstructive joint surgeries. The role contributes to the development of manufacturing processes for new products and supports quality-system documentation, process validation, development builds, design for manufacturability, and manufacturing strategy. It also involves collaboration with development teams, participation in lean and Kaizen activities, and coaching technicians or other engineering employees. The position requires a bachelor’s degree in science, mechanical engineering, or a related engineering discipline, and at least 10 years of experience in process or manufacturing engineering. Travel is less than 5%. Physical requirements include lifting, carrying, and pulling up to 50 pounds and standing or sitting for extended periods. Enovis states that it does not provide employment visa sponsorship; applicants must already have full-time U.S. work authorization without requiring sponsorship.

Requirements

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.
Expert-level knowledge of Design for Manufacturability, with demonstrated ability to influence product design, establish manufacturing strategies, and optimize designs for manufacturability, quality, cost, and scalability.
Advanced proficiency interpreting and applying ASME Y14.5 standards, including datum strategies and complex dimensional requirements for precision-machined components and assemblies.
Expertise in manufacturing processes related to orthopedic implantable products and surgical instruments.
Experience with CAD software such as SolidWorks and Mastercam.
Knowledge of lean manufacturing, process control concepts, Design of Experiments, process validation, and product/process FMEA.
Experience using problem-solving and process-improvement methodologies such as Six Sigma and DMAIC.
Experience with measurement systems such as CMMs, vision inspection, and profilometers.
Ability to lift, carry, and pull up to 50 pounds and stand or sit for extended periods.
Must already have full-time U.S. work authorization, both now and in the future, without requiring employment visa sponsorship.

Nice To Haves

Experience with data analysis software such as Minitab.
A master’s degree in engineering.
Experience with metals or plastics machining.

Responsibilities

Serve as the primary process and manufacturing expert on cross-functional new product introduction teams.
Assess process capabilities, prioritize improvement opportunities, and implement process improvements for new development projects.
Apply technical knowledge to design and develop processes, procedures, tooling, and automation.
Execute functional deliverables related to CAPA, project management, and quality systems.
Plan, organize, and conduct manufacturing technical reviews.
Complete documentation required by quality systems, including bills of materials, routers, and FMEAs.
Write and review validation protocols and reports for new processes.
Oversee project development builds using technical work requests.
Provide Design for Manufacturability input to engineering print packages.
Communicate process and manufacturing limits and capabilities to the development team.
Contribute ideas to or generate intellectual property submissions.
Train manufacturing personnel when required as part of a validation.
Participate in lean reviews and Kaizen events.
Coach technicians or other engineering employees.