Product Development Engineer-Knees

ate 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 product development within project(s) from proposal to final design/release for the assigned project by performing the following duties. Works with a cross-functional product team consisting of developing surgeons, product development engineers, marketing product managers, manufacturing engineers, regulatory, quality engineers and purchasing in the design and development of surgical instruments and implants medical devices used in Total Knee Arthroplasty.

Key Responsibilities:

• Identifies User Needs of product by engagement with Orthopedic Surgeons & Marketing

• Translations User Needs into Design Requirements/Inputs to meet market need while complying with global regulatory requirements (FDA / EU MDR) and internal/external standards

• Creates product designs that meet the user needs/design requirements

• Reviews and prepares information for invention disclosure and patents.

• Collaborates with cross-function teams (Quality, Manufacturing, Marketing, Regulatory, Purchasing, Project Manager) on prototypes and initial production units for design evaluation, design verification, design validation and process validation.

• Create product designs and drawings that are appropriate for design for manufacturability and inspection by conducting reviews

• Identifies critical to quality product dimensions based on product intended use, design requirements, associated user risks and the design itself to ensure appropriate quality control inspection plans are generated

• Defines verification and validation activities relative to user needs and design requirements to reduce risks in compliance with Enovis procedures and global regulatory requirements (includes completing tolerance stack-ups, testing, finite element analysis and cadaveric design evaluation/validation within a simulating operating room environment)

• Compiles Design Dossiers or Design History Files

• Works with Project Management on project plan/schedule and with management on budget plans/proposals

• Assures proper preparation of documentation as required per project plans including user needs, design requirements, risks, surgeon feedback / IP, engineering drawings, test plans, manufacturing instructions, design verification and validation, engineering change notices, artwork and other supporting engineering documents.

• Works with manufacturing, supply chain and quality assurance, reviews and monitors quality and process improvements for new product development.

• Assists fellow product development engineers, engineering manager & director on development of new products.

• Attends cadaver labs for design evaluation, design validation and for educational 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

• Provides project updates to customers, upper management, and cross-functional team member on a reoccurring basis

• 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.

• Receives instructions and pre-established guidelines to perform the functions of the job

• Majority of time is spent in a resource capacity

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:

• Education: Minimum BS in Mechanical Engineering, Biomedical Engineering, or equivalent or an equivalent of 8 years directly-related work experience as a product development engineer within the medical device industry

• Work Experience: 4 years minimum of full-time product development engineering experience within the medical device industry

Travel Requirements:

• Up to 5% domestic and potentially international to attend tradeshows, seminars, design evaluation/validation labs, meet with surgeons, view surgeries and visit suppliers

Desired Characteristics:

• 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; presentation skills required

• 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 on potentially unsafe conditions; uses equipment and materials properly

• Understands ASME GD&T standards of application to product design

• Knowledge of various manufacturing primary processes including subtractive machining, additive manufacturing, forging, casting, plastic molding along with secondary processes including bead blasting, laser and GTAW welding, electropolishing, various coatings, passivation, laser etch and material science for application in new product development

• Finite element analysis experience desired

• SolidWorks CAD modeling preferred, NX Unigraphics desired

• Microsoft Office Suite software proficiency

• Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, statistical knowledge for application of sample size determination and hypothesis testing

• Knowledge in advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations

• Experience working with FDA QSR and EU MDR medical device regulatory requirements, and industry/regulatory body recognized technical product standards knowledge

• Ability to respond to common inquiries or complaints from customers, regulatory agencies, sales representatives, design surgeons, or members of the business community

• 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

• Knowledge of engineering change management systems

• 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

• Physical Demands:

• While performing the duties of this job, the employee is regularly required to sit, talk, and hear

• The employee frequently is required to sit and use hands to operate computer keyboard, and telephone

• The employee is frequently required to stand, walk, and reach with hands and arms

• This position works in a typical office/manufacturing/warehouse environment

• The employee must occasionally lift and/or move up to 30 pounds

• The noise level in the work environment is usually moderate

• This position works in a typical office environment

• Perform job duties for 8 or more hours a day

• Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus

"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 https://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.

Join us in creating better together.

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 https://www.enovis.com.

EOE AA M/F/VET/Disability Statement

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.