Client prefers spine experience with metal structural/fixation products over osteobiologicsPosition Summary:

Responsible for providing engineering and product development activities for new product development and

sustaining/product support projects. 

Activities are performed on projects with guidance and direction by a

senior engineer, group director or higher management. 

The scope of work encompasses moderate to significant technical difficulty with various amounts of management involvement.  Position typically leads a project or development effort of smaller scope while also providing support for larger scale projects. 

This position is expected to execute project and design tasks with minimal technical supervision and moderate overall management.

Essential Job Functions:

 - Key responsibilities include some project

management and detailed hands-on development work such as:

 - CAD design

 - Intellectual property

 - Surgeon interaction

 - Prototyping

 - Testing

 - Design control documentation

 - Transfer to manufacturing

 - Supporting FDA submissions

 - Supporting product launch

 - Follow-up on design items

 - Leads design and development efforts from conception thru prototyping and production with a moderate amount of management interaction and guidance.

 - Learning and applying project management skills; capable of planning and leading execution of projects with moderate complexity.

 - Completes assigned projects at an aggressive pace.

 - When designing and problem solving, uses an organized approach to identify key constraints, consider an appropriate range of options and choose an optimal solution.

 - Generates unique, creative concepts that are innovative and technically sound solutions to challenging design problems.

 - Creates appropriate test plans with input from engineering management or a more senior engineer.  Executes test plans with minimal guidance.  Writes technically sound test protocols

and reports documenting the testing performed.

 - Participates in design meetings with surgeons and additional Lanx personnel.

 - Writes defendable rationale for DCR changes to existing products (both Class I and II).

 - Tracks project expenses

 - Provides support in the preparation of a 510(k) submission, with excellent attention to details.

 - Prepares clear and technically correct design documents based on company SOPs and documentation conventions.

 - Demonstrates understanding of spinal anatomy and basic spine biomechanics, as applicable to assigned projects.

 - Participates in technical discussion on the merits of designs as they relate to spinal surgery.

 - Puts in time that is required to fulfill duties

(job scope frequently requires more than 40 hrs/week, including some weekends).

Knowledge, Skills and Abilities:

 - Familiar with or learns about spinal surgery

techniques relating to assigned projects.

 - Familiar with or learns about mainstream

competitive products relating to assigned projects.

 - Capable of both creative and detail-oriented design

work.

 - Organized. 

Must plan and execute multiple concurrent assignments and complete tasks

at an aggressive pace.

 - Understands the importance of presenting a

professional image to surgeons and other customers.

 - Able to apply basic project management skills to

assigned tasks; capable of overseeing the work of a design resource assigned to

the project

 - Thorough knowledge of design analysis.  Able to use applicable tools (stress

analysis, FEA, etc.) to confirm the integrity of designs.

 - Working knowledge of GD&T. Able to apply basic GD&T

principles to engineering prints.

 - Has a basic understanding of manufacturing

processes and how they affect design decisions.

 - Proficient in Solidworks.

Work Experience Qualifications:

 - 6-10 years progressive product development experience in medical devices

  - At least 1 year in spine

Education and/or Certifications:

 - BS in mechanical or biomedical engineering

 - Advanced technical degree preferred