Responsible for the design, development, and processing of implants and instruments. Work is expected to encompass both the development of new products and maintenance of existing products. Position will lead development aspects of the project as a core team member.
Principal Duties and Responsibilities
Leads the development of new 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.
Designs for manufacturability, inspectability and optimum cost
Participates in root cause analysis for problem solving
Contributes to generation of a comprehensive protocol for testing/analyzing the product
Coordinating product evaluation with surgeon
Prepares definitive new product specifications or modifies existing specifications
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
• Working knowledge of and experience with new product development
• Demonstrated ability to methodically investigate and resolve problems using current technology
• Ability to assess own progress on assignments relative to project schedule
• Ability to process customer complaints, engineering changes and nonconforming product
• Professional, concise, tactful and sensitive in communications. Accomplishes objectives when communicating with internal personnel, and external customers and vendors.
• Demonstrated good written and verbal communication skills including presentation skills
• Familiarity with drafting standards and geometric dimensioning and tolerancing
• Assures preproduction quality requirements are met
• Microsoft Office Suite and Project
Minimum B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines, 3-5 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 5% as necessary