
Position: Project Engineer Design Team Member
Role within team: Each team member will complete any assigned responsibilities
related to the R&D mission or key role elements.
- Assignments will be based on the team members' attributes,
current team priority goals and performance benchmarks. Each
team member must seek and work to acquire product development
know-how specific to the assistive and rehab technology fields,
with an emphasis on external orthotic and prosthetic technology.
Therefore, successful team members will be generalists capable
of acquiring specialized know-how to push the envelope within
our field of invention in a small team environment.
Job
Duties:
- Research relevant emerging technologies, materials,
processes, vendors using the internet, trade journals, registers,
engineering texts, etc. related to new and existing product(s)
and concepts
- Confidentially, as trade secrets, reduce assigned
new product concepts to practice for patenting
- Utilize solid modeling and FEA of new concepts
to optimize initial prototypes.
- Prototype new concepts in-house or out-sourced
as dictated by staffing, budget and efficiency. Use in-house
lathe, mill, etc. to create prototype parts.
- Design testing fixtures, protocols and collect/analyze
data for new prototype performance. Tests must simulate patient
usage and design limits.
- Complete prototype and product technical documentation
(parts and assembly drawings, mfg. procedures, BOMs, etc.)
necessary for outsourcing of mfg., in-house assembly/fabrication
and commercialization of new products.
- Document time spent on each project within
performance benchmark and project management systems to measure
R&D goal attainment, cycle times and efficiency. Maintain
inventor-ship logs for all proprietary concepts, their reduction
to practice, testing and evolution through introduction, project
completion or abandonment.
- Maintain organized uniform team project files
(paper and electronic as feasible/desirable) for all prior
art searches, competitive literature, research, articles,
market demographics, design parameters, etc.
- Document, investigate and re-mediate all field
product failures in compliance with FDA, CE and in-house ECO/MCO
systems.
- Update specification within uniform team system
for commercial Ultraflex products (drawings, BOMs, etc.) as
needed to assure continued appropriate manufacturing and procurement
when design revisions are made. Maintain all R&D and engineering
files on site, with appropriate security to prevent theft
or improper public disclosure.
- Attend trade shows and medical conferences
to assess emerging and competitive technologies, gain understanding
of relevant pathologies, anatomy, physiology, biomechanics
and treatments.
- Interface effectively on phone and in-person
with clinical advisors and customers on relevant projects
to gain understanding of design requirements and intended
use.
Position
Attributes Needed:
education: BS in mechanical, electrical, bio-medical
or biomechanical engineering.
training: AutoCAD or Solid Works proficiency
experience: 1-5 year's product development experience
in consumer or healthcare arena in smaller team environment with
multiple duties contributing to each phase of product development.
Hands-on shop skills for prototyping using mill, lathe, etc. Testing
and validation experience (life tests, destructive tests, etc.)
Regulatory experience in FDA, CE or quality systems a plus.
behavioral: Understands team approach to R&D. Able to
communicate openly, honestly and positively during design reviews
of both their own and other team members' work. Receives constructive
criticism well without taking it personally. Willing to admit
when you don't know the answer and able to formulate and ask the
right questions from others to achieve the best solutions. Curious
and analytical personality that can boil down complex data into
fundamental parameters and design elegant, functional and simple
solutions. Strong sense of inter-relationship between form and
function.
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