Responsible for the design, development, and processing of patient specific implants and instruments based upon individual patient anatomy or conditions. Work is expected to encompass both the development of new products and maintenance of existing products. Position will lead large scope projects, multiple projects, or projects of significant strategic importance to the business, as well as individual patient cases. Management of engineering staff of equal or lower positions may be assigned.
Principal Duties and Responsibilities
• Leads the development of new patient specific products and manufacturing processes. Identifies all tasks required to complete project assignments according to Design Control procedures. Prepares work plans outlining estimated manpower requirements and development costs. Recommends project budget and schedule to carry out programs on a timely basis. These products may be individual products for a patient specific case or FDA cleared products intended for use in conjunction with patient specific devices.
• Designs or directs design work for manufacturability, inspect ability and optimum cost
• Conducts or participates in root cause analysis for problem solving
• Contributes to generation of a comprehensive protocol for testing/analyzing the product
• Coordinating product evaluation and patient specific case proposal discussions with surgeon
• Prepares definitive new product specifications or modifies existing specifications
• Prepared patient specific design proposals for approval by surgeon for multiple cases.
• Generates or updates design assurance documentation for the product
• Completes stress analysis on new or existing designs
• Generates and/or manages the creation of prototype models to evaluate new design concepts
Expected Areas of Competence
• Full working knowledge of and significant level of experience with new product development including project management of multiple complex projects
• Demonstrated ability to methodically investigate, determine appropriate solution and resolve significantly complex problems using current and new technologies. Ability to develop or identify new technologies to address problems.
• Ability to develop large scale project schedules, and to assess and manage cross functional team’s progress on assignments relative to project schedule
• Ability to process customer complaints, engineering changes and nonconforming product, and make recommendations based upon business principles
• Professional, concise, tactful and sensitive in communications. Accomplishes objectives when communicating with internal personnel, and external customers and vendors. Able to diplomatically negotiate with a requester concerning design, process, scope or timetable. Strong ability to represent the department and company.
• Demonstrated good written and verbal communication skills including presentation skills.
• Advanced working knowledge of drafting standards and geometric dimensioning and tolerance
• Assures preproduction quality requirements are met
• Leads or participates in the creation and improvement of processes
• Microsoft Office Suite and Project
- Minimum B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines, 8+ years of experience: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering.
- Medical device, particularly Orthopaedic industry, experience preferred.
Up to 10%