- Working with Development Engineers to develop, review and approve the below items from the DHF & RMF:
o 4 years of medical device design experience
o Risk Management
o FMEA
o Design Verification & Validations
o Design Controls
Job Description:
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 small scope project as a project leader or portions of larger scope project as a core team member. Position may be required to provide on-the-job training to new engineers.
Principal Duties and Responsibilities
Key Team member of Integration/Remediation of new acquired product. Identifies all tasks required to complete project assignments according to Design Control procedures.
Designs for manufacturability, inspectability, and optimum cost
Participates in root cause analysis for problem solving
Generates 3d models and product drawings
Contributes to generation of a comprehensive protocol for testing/analyzing the product
Executes generated testing as required
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
Full working knowledge of and moderate level of experience with product development and product lifecycle
Demonstrated ability to methodically investigate, determine appropriate solution and resolve problems using current technology
Ability to develop project schedule and assess cross functional teams 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.
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
Microsoft Office Suite and Project
Education/ Experience Requirements
Minimum B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines, as well as a minimum of 4-5 years of experience: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering.