Product Development Engineer - Upper Extremity

Enovis; Austin (TX); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Vacation and Holidays

Job summary

Enovis is seeking a Product Development Engineer for Upper Extremities in Austin, TX. You will join a cross-functional team to drive development of orthopedic implants and surgical instruments, translating surgeon needs into robust designs.

The role requires hands-on CAD work, design documentation, and collaboration with marketing, manufacturing, and QA to ensure quality and regulatory alignment. A strong mechanical engineering background and 4+ years of relevant experience are essential.

Qualifications

• Minimum 4 years of design/development experience in medical devices or related fields.
• BS in Mechanical Engineering or equivalent.
• Ability to present information to groups of managers, clients and customers.
• Familiarity with regulatory environments (FDA/ISO) and design controls.

Responsibilities

• Participate in all phases of product development from proposal to release.
• Develop surgical instrument and implant designs and related documentation.
• Use 3-D modeling to develop concepts and mechanisms (SolidWorks).
• Maintain Design History Files and design verification/validation plans.

Skills

SolidWorks

Design experience

Mechanical Engineering

Regulatory awareness

Education

BS in Mechanical Engineering

Tools

3D CAD (SolidWorks/NX)

Job description

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.

Who We Are

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 R&D 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

Product Development Engineer - Upper Extremities

Reports To

Sr. Engineering Manager

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. 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

Participates in all aspects of the projects from proposal to final design/release for the assigned project by performing the following duties. Works with a cross-functional product team consisting of product development engineers, marketing product managers, manufacturing engineers, regulatory and QA engineers in the design and development of surgical instruments and implants medical devices used in Total Shoulder Arthroplasty.

Key Responsibilities

• Participates as an active member of the New Product Development Team:
• Identifies and incorporates surgeon design requirements and product characteristics
• Confers with cross-function teams (by way of example and not exclusion, Manufacturing Engineering, Purchasing and Regulatory); accepts and completes tasks as assigned
• Creates product designs and documentation used to substantiate those devices (i.e. risk assessments, verification / validation activities, design review documentation, etc.)
• Uses 3-D Modeling to develop concepts and mechanism design (Solidworks)
• Compiles Design Dossiers or Design History Files
• Assuring compliance to FDA and ISO regulations and internal procedures
• Establishing and maintaining project schedule and budget
• Reviewing designs for feasibility, accuracy and technical soundness
• Defining and implementing testing requirements associated with projects
• Participate in the evaluation of new concepts presented to Enovis Surgical by surgeons or other Enovis Surgical employees.
• Collaborate / lead other engineering personnel in formulating project plans, designs, cost estimates, and specifications.
• Assures proper preparation of documentation as required per project plans including user needs, surgeon feedback / IP, engineering drawings, test plans, manufacturing instructions, design verification and validation, engineering change notices, artwork and other supporting engineering documents.
• Working with manufacturing, supply chain and quality assurance, reviews and monitors quality and process improvements for new product development.
• Participates in surgeon symposia, focus groups and surgeon consultant meetings
• Assists product development engineers and the Engineering Manager or Director of Shoulder Product Development with New Product Development projects
• Attends cadaver labs for learning purposes
• Works with both the marketing team and customers to develop conceptual designs, typically in the form of SLA models or metal prototypes of the product and present those designs back to the customers for evaluation
• 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
• Develops project plans using appropriate planning software and periodically report on the progress of the project to upper management
• Develops detail engineering drawings, CAD modeling and release through design change system; understands GD&T and can apply it in tolerance stacking activities
• Works through internal prototype shop or contract through external vendors on developing prototypes.
• Maintain basic knowledge of competitive technologies, in addition to medical, clinical, technical and biomedical developments in the field.
• Maintain communications with customers and suppliers.
• Relies on instructions and pre-established guidelines to perform the functions of the job
• 80% of time is spent in a resource capacity. 20% of responsibilities are in leadership activities.

Minimum Basic Qualifications

• A minimum of 4 years of design / development experience; engineering co-op or internships is strongly desirable
• BS in Mechanical Engineering, Biomedical Engineering, or equivalent
• Ability to present information and respond to questions from groups of managers, clients, and customers
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, sales representatives, design surgeons, or members of the business community
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations
• Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, statistical analysis
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
• To perform this job successfully, an individual should have knowledge of Word Processing software; spreadsheet software; internet software; contact / change management systems

Desired Characteristics

• Experience with 3D CAD packages (SolidWorks or NX preferred)
• Experience in medical devices and/or orthopedics preferred
• Experience working in a regulated industry preferred

Work Environment

• While performing the duties of this job, the employee is exposed to the manufacturing environment as required by local ordinance
• While performing the duties of this job, the employee is exposed to the office environment as required by local ordinance
• 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

"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

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. Visit www.enovis.com to learn more.

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.

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.