Product Development Engineer-Orthopedics

Job Title: Senior Product Development Engineer- Orthopedic Implants
Job ID: 117- PDE-Ortho

SalaryCommensurate with experience.
Benefits: Comprehensive benefits
Location: Ft. Lauderdale, FL

Apply online via our website www.MRIOrlando.com; go to "Find a Position" and enter Keyword "117"

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ORTHOPEDIC (Knee) "Dream Team" Recruitment Underway

If you've ever wanted to work for a well-funded orthopedic start-up company with a high probability of being one of the major success stories in the industry, please apply below. Our firm has been helping to quietly assemble a "dream team" of some of the brightest and best in the medical orthopedics: Implant Engineers, Robotic Engineers, Software and Project Engineers, Research & Development, Manufacturing, Operations, Clinical, Finance, Quality, Sales and Marketing. If you're the best at what you do and have the experience, education, and drive to be a "legacy member" of a team poised for success, we want to talk to you. Confidentiality is guaranteed; please contact the Sales Manager directly via phone should you have contractual concerns 407-898-4440.



Company Summary

Our client is a venture-backed medical device company providing innovative solutions to the orthopedic knee market. A proven management team applies a patient-centric healthcare vision with FDA-cleared 510(k) robotic technology, allowing them to provide revolutionary therapies to an enormous, yet vastly underserved patient population that suffers from earlier stage degenerative joint disease of the knee. The proprietary technology consists of a unique knee replacement implant system and an enabling robotic technology that empowers orthopedic surgeons to provide less invasive solutions for compartment specific knee disease. This has the potential to shorten recovery time and enhance post-operative lifestyle of the patients who are treated.




Responsibilities:
Design of knee-related product concepts and improvements including design modeling and drawings, documentation management from concept stage through production and commercial release.
Work closely with Orthopedic Surgeons, clinicians, and Research & Development to create product design concepts, effective design improvements of surgical implants, and implants.

- Generate product models and detailed implant and instrument drawings utilizing CAD system
Create and maintain project plans and FDA complaint DHF as well as, support 510(k) submissions or IDE clinical studies.
Develop verification and validation test protocols meeting design control according to ASTM standards, perform test activities, and complete test reports with internal and external resources.
Work with outside manufacturers and vendors to develop prototypes and improve manufacturability.



Qualifications:
Masters degree in Mechanical/Biomedical Engineering (Bachelor degree will be considered based on experience).
Minimum of five years of engineering experience in the orthopedic industry, with a minimum of three years experience in knee implant design
Working knowledge of 3D CAD software (Pro-E, Unigraphics, Solidworks, AutoCAD, or similar).

- Experience in FEA analysis, Testing strategy, data collection, and reporting related to design and analysis of implant products (3-D and 2-D)
Able to demonstrate project management skills, with efficient use of project resources.
Hands-on engineer with a demonstrated success in developing innovative products from concept through market release.
Experience in the creation of solid models and detailed drawings for new designs, maintain design control documentation & project files following FDA and ISO design control requirements

- Superior communicator with demonstrated ability to adequately represent and reflect company philosophy to customers, investors, regulatory agencies, and industry peers
Proficient in preparation of reports and budgets.
Participation in internal and external cadaver labs, user training, and support of clinical use of systems.
Knowledge and experience in creation and maintenance of project DHF to meet QSR requirements
Highly creative and innovative, able to demonstrate examples of thinking outside the box.
Knowledge of implant manufacturing technologies

- Image-Guided Surgery (Navigation) and/or Robotic application experience is desired, but not required.
Extensive understanding of orthopedic knee market, with specific knowledge of MIS techniques and approaches



Competitive Salary and Benefits





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­­­­­­­­­­­­­­­­­­­­­­Management Recruiters of Orlando works exclusively in the area of EMERGING MEDICAL TECHNOLOGY

· MEDICAL DEVICE (510K, IDE, PMA, VC, Incubator stage) IMAGING (CT, MR, PET, Ultrasound, HIFU, Fluoroscopy, PACS, Mammography) NAVIGATION (IGS, CAS, DBS, Robotics, )
· EMERGING AND CONVERGING Radiologic and Surgical Treatment Solutions

Management Recruiters of Orlando Lakes
3751 Maguire Boulevard Suite 221
Orlando, FL 32803

(407) 898-4440
www.MRIOrlando.com
[Click here for email]
REQUIREMENTS
Please see Job Description