Enovis

Job Description:

At Enovis™ we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind 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.

As a key member of the Research & Development 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/High Level Position Summary:

Participates in all aspects of the New Product Development 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 upper-level 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 Joint Arthroplasty.

Key Responsibilities:

• Participates as an active member of the New Product Development Team:
• Helps to identify surgeon requirements and product characteristics.
• Collaborates 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, with necessary supervision, used to substantiate those devices (i.e. risk assessments, verification / validation activities, design review documentation, etc.)
• Uses 3-D Modeling to document designs and design changes (Solidworks)
• Compiles Design Dossiers or Design History Files
• Assists with document preparation necessary for 510(k) application.
• Participates in surgeon symposia, focus groups and surgeon consultant meetings.
• Assists product development engineers and the Engineering Manager of Foot & Ankle Product Development with New Product Development projects.
• Attends and assists with industry meetings and internal cadaver labs.

Additional Job Responsibilities:

• Works with both the marketing team and customers to develop conceptual designs, typically in the form of 3D printed plastic or metal prototypes and present those designs back to the customers for evaluation.
• Maintains documentation necessary for a Design History File (DHF), including Design Input Documents, Design Validation Plans/Reports, Test Protocols/Reports, and Design Input/Output Matrix.
• Assist the PMO with development of project plans and periodically report on the progress of the project to management and executive leadership team.
• Develops detailed engineering drawings, CAD modeling and release through the Enovis QMS.
• Works through internal prototype shop or contract with external vendors on developing prototypes.
• Schedules and directs product team meetings as needed in the absence of upper-level product development engineers or NPD manager; assuring timeliness of project execution.
• Relies on instructions and pre-established guidelines to perform the functions of the job. 
• 90% of time is spent in a resource capacity. 10% of responsibilities are in leadership activities.

Competency:

• 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.

Minimum Basic Qualifications:

• 0-3 years of experience
• BS in Mechanical Engineering, Biomedical Engineering, or equivalent
• Experience in medical devices and/or orthopedics preferred.
• Experience with 510(k), MDR, and other applicable regulations preferred.
• Ability to effectively 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 (with reasonable supervision and time to investigate individual requests).
• 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, 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; manufacturing software and contact management systems.
• Experience with 3D CAD packages (SolidWorks preferred)

Work Environment:

• While performing the duties of this job, the employee is exposed to the manufacturing environment.
• While performing the duties of this job, the employee is exposed to the office environment.
• 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.

Watch this short video and discover what creating better together means to us at Enovis:

Our Enovis Purpose, Values and Behaviors on Vimeo

We offer a comprehensive benefits package which 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 and 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.

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.

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.