Job Requirements
- 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
Documentation
- 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
Supervisory Responsibilities
- 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
Supervision
- 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.
Support
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
Requirements
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
Physical Demands
- Must perform light lifting
- Working in a controlled environment fully gowned
- Periodic traveling
- Ability to work extended hours as necessary