Product Development Engineer II-Knees

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 Enovis Surgical 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 Description 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 Knee Arthroplasty.

Job Description:

• 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 (https://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
  • Compile 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 Knee Product Development with New Product Development projects
• Attends cadaver labs for learning purposes

 Additional Job Description:

• 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
• Majority of time is spent in a resource capacity

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

Qualifications:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

Education / Experience:

• 3-5 years of design / development experience; engineering co-op or internships is strongly desirable
• BS in Mechanical Engineering, Biomedical Engineering, or equivalent
• 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
• To perform this job successfully, an individual should have knowledge of Word Processing software; spreadsheet software; internet software; contact / change 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 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

ABOUT DJO GLOBAL
DJO Global is a leading global developer, manufacturer and distributor of high-quality medical devices that provide solutions for musculoskeletal health, vascular health and pain management. Our products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Our products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of our medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. Product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. Our surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. Our products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, ProCare®, Exos™, Dr. Comfort®, DonJoy Performance® and DJO® Surgical.

For additional information on the Company, please visit https://www.DJOglobal.com.

DJO is a growing subsidiary of diversified technology leader Colfax Corporation

EOE AA M/F/VET/Disability

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.