#R0027300
those devices (i.e. risk assessments, verification / validation activities, design review documentation, etc.) - Uses 3-D Modeling to develop concepts and mechanism design - 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 5 years of design / development experience; engineering co-op or internships is strongly desirable
BS in Mechanical Engineering, Biomedical Engineering, or equivalent
Prior knowledge of and experience with Word Processing software; spreadsheet software; internet software; contact / change management systems
Prior experience with 3D CAD packages (SolidWorks preferred)
Desired Qualifications:
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
Travel Requirements:
< 25%
Physical Requirements:
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
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
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.