Sr. Product Development Engineer-Shoulders

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 Surgical 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:
Senior Product Development Engineer
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
To perform the job successfully, an individual should demonstrate the following competencies:
Analytical - Synthesizes complex or diverse information
Design - Demonstrates attention to detail
Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; uses reason even when dealing with emotional topics
Project Management - Communicates changes and progress
Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills
Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification
Written Communication - Writes clearly and informatively; varies writing style to meet needs; able to read and interpret written information; writes detailed test protocols/reports
Quality Management - Looks for ways to improve and promote quality; demonstrates accuracy and thoroughness
Business Acumen - Understands business implications of decisions
Diversity - Shows respect and sensitivity for cultural differences; promotes a harassment-free environment
Judgment - Exhibits sound and accurate judgment; includes appropriate people in decision-making process
Safety and Security - Observes safety and security procedures; reports potentially unsafe conditions; uses equipment and materials properly
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.
Minimum Basic Qualifications:
A minimum of 8 years of design / development experience; engineering co-op or internships is strongly desirable
BS in Mechanical Engineering, Biomedical Engineering, or equivalent
Knowledge of Word Processing software; spreadsheet software; internet software; contact / change management systems
Experience with 3D CAD packages (SolidWorks preferred)
Desired Characteristics:
Experience in medical devices and/or orthopedics preferred
Experience working in a regulated industry preferred
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