Confidential Posting
Position
Summary:
Responsible for providing support of engineering
and product development activities for new product development and
sustaining/product support projects.
Activities are performed on projects with guidance and direction of
another engineer/project leader, group director or higher management.
The scope of work encompasses moderate to
significant technical difficulty with moderate management involvement. Position typically provides 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 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 |
Supports design and development efforts from
conception thru prototyping and production with a moderate amount of management
interaction and guidance.
Completes assigned tasks 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.
Provides support in creating appropriate test plans
with input from engineering management or a more senior engineer.
Executes test plans with moderate guidance.
Assists in writing technically sound test protocols
and reports documenting the testing performed.
Provides support in the preparation of a 510(k)
submission, with excellent attention to details.
Prepares clear and technically correct design
documents based on Lanx SOPs and documentation conventions.
Demonstrates understanding of, or learns about,
spinal anatomy and basic spine biomechanics, as applicable to assigned
projects.
Assists in writing defendable rationale for DCR
changes to existing products (both Class I and Class II).
Participates in design meetings with surgeons and
additional Lanx personnel.
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:
Has a basic understanding of design analysis. Uses appropriate tools (stress
analysis, FEA, etc.), under the guidance of more senior personnel, to verify
the integrity of designs.
Has a basic understanding of manufacturing
processes and how they affect design decisions.
Is capable of both creative and detail-oriented
design work.
Familiar with or learns about spinal surgery
techniques relating to assigned projects.
Familiar with or learns about mainstream
competitive products relating to assigned projects.
Organized.
Must plan and execute multiple concurrent assignments and complete tasks
at an aggressive pace.
Proficient in Solidworks.
Understands the importance of presenting a
professional image to surgeons and other customers.
Able to apply basic time management skills to
assigned tasks and use of applicable resources.
Work
Experience Qualifications:
4-8 years of product development experience with
focus on medical devices
At least 1 year of spine experience
Education
and/or Certifications:
BS in mechanical or biomedical engineering
Advanced technical degree preferred