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 medium scope projects, multiple small projects or large portions of a large project as a core team member. Management of engineering staff of equal or lower positions may be assigned.
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 or directs design work for manufacturability, inspectability 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 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
Full working knowledge of and high level of experience with new product development including project management of medium to complex projects
Demonstrated ability to methodically investigate, determine appropriate solution and resolve problems using current and new technologies
Ability to develop project schedule, 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 regarding a design, process, scope or timetable.
Demonstrated good written and verbal communication skills including presentation skills
Working knowledge of drafting standards and geometric dimensioning and tolerancing
Assures preproduction quality requirements are met
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, Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering.
3-5 years of experience in new product development including project management of medium to complex projects