Job Description:

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 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
  • 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.

• 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)

• 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

• < 25%

• 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

• 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