Design Engineer MedVenture Technology Corporation
THIS JOB HAS EXPIRED
New product design & development
Apply engineering knowledge to the design and development of new products and product changes and enhancements to existing products
Perform functions to establish feasibility of concepts and determine specific design inputs and requirements for new products
Perform risk analysis and reliability activities for new and existing products
Responsible for Technical Device Reviews
Design new and existing products including, but not limited to, solid modeling (SolidWorks preferred), specifications and tolerances
Support the development of product test methods
Support the development of incoming inspection requirements
Responsible for design and development of product packaging and labeling
Perform design verification and validation to include protocol development, builds, testing, and reports
Maintain current knowledge of competitive technologies in the medical device industry
Support the development of manufacturing processes and procedures
Communicate design related issues with internal and external team members
Support the project manager in project planning and execution of design related activities
Write invention disclosure to support patent applications
Provide mechanical engineering support in the resolution of product complaints and/or safety issues.
Other duties as assigned
Provide proper documentation for design tasks to support FDA Quality System requirements, other regulatory bodies and customer requirements. (e.g. lab notebooks or technical memos)
Develop and manage the Design FMEA
Develop and manage the design traceability matrix (DTM)
Formal and informal build protocols and reports
Assign work to technicians and temporary employees as needed
Mentor lower level design engineers
Oversee and assist in the selection of outside vendors and consultants as required
Provide leadership and direction on project teams as it relates to the design engineering functions
Provide leadership and direction for product development process improvements
Level of Activity
Engineer I Support: Is a mentoree and a higher level Design Engineer will provide direction and review their work prior to submitting deliverables
Engineer II Support/Lead: May be a mentoree or a mentor, lower level activities can be performed without supervision. Supervision may be required for larger more complex deliverables.
Senior Engineer Lead: Is a mentor, all activities are performed without supervision.
Principal Engineer Lead/Consult: Is a mentor, all activities are performed without supervision.
Engineering Fellow Consult: Is a mentor, all activities are performed without supervision.
Provide support of an output or activity to a higher level
Design Engineer ? Lead: lead an output or activity, may have support of a lower level
Design Engineer ? Consult: provide guidance to a lower level Design Engineer
Job Experience & Education
Four year engineering degree, BSME or BSBME preferred. Relevant experience in lieu of a degree shall be considered on a case-by-case basis.
Ability to identify and create unique and innovative designs.
Ability to formalize concepts for production fabrication of parts and assemblies.
Ability to create detail drawings for production fabrication of parts and assemblies. Knowledge of materials and the characteristics of parts when fabricated from different materials (e.g. polymers and metals).
Knowledge of tooling and process to produce component parts.
Understanding of various manufacturing and production monitoring techniques.
Ability to use analytical techniques for design verification, problem and root cause analysis.
Working knowledge of both FDA and CE design controls
Level of Experience
Engineer I: 1-5 years Equivalent job experience
Engineer II: 6-10 years Medical device job experience
Senior Engineer: 11-15 years Experienced in all job requirements within the medical device industry
Principal Engineer: 15-20 years Experienced in all job requirements within the medical device industry
Engineering Fellow:20+ years Experienced in all job requirements within the medical device industry
Must perform light lifting
Working in a controlled environment fully gowned
Ability to work extended hours as necessary
||Jeffersonville, IN |
THIS JOB HAS EXPIRED