Leesburg Categories:
Director of Research and Advanced Development K2M
THIS JOB HAS EXPIRED
Plans, directs, and conducts technical feasibility and research activities on projects of a very sophisticated nature containing technology in the areas of: biomechanics, biomaterials and mechanisms; orthopedics, neurosurgery, and implantable devices. Researches and reports on the commercialization potential of ideas as well as the intellectual property issues. Prepares appropriate patent submission documentation and works closely with patent attorneys to protect company?s IP position. Personally contributes to feasibility activity by providing original concept work overall, and performing some detail design analysis.include the following:
Manage the process of assessing the feasibility of new products and product concepts using existing and emerging technologies.
Prepare and review information for patent applications. Serve as company?s principal contact with patent attorneys. Track the progress of the new IP filings by the attorneys.
File provisional patents for early stage inventions
Review utility patent conversions from previously filed provisional patents.
Lead the conceptual development of inventions and disclosed ideas thru the initial conceptual stages to facilitate management decisions on fit and feasibility.
Present feasibility progress information to senior staff including: patentability, design feasibility and progress towards development schedule.
Work with inventors, the BSA, and directly with customers, to ensure inventorship and patent protection are secured in a manner that meets the company?s interests.
Support regulatory submissions including 510(k), PMA, and CE mark on new and developing technologies.
Maintain sufficient and accurate technical records in an engineering notebook per company policies
Bachelor?s degree in Mechanical Engineering from a top engineering school, Master?s degree preferred.
7 ? 10 years engineering experience in the medical device field.
Minimum 5 years experience in product development in the orthopedic implant business
Must have prior experience in hospital and operating room environments
7 ? 10 years engineering experience in the medical device field.
Minimum 5 years experience in product development in the orthopedic implant business
Must have prior experience in hospital and operating room environments
Must have a proven track record of effective, organized, thoughtful team leadership
Must have a demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.
Must have the ability to professionally and effectively present information to, and receive feedback from surgeons, hospital staff and other external partners.
Extensive knowledge of biomechanical design and manufacturing processes
In-depth understanding of the patent process and good overall familiarity with orthopedic device patents.
Clear understanding of quality standards, regulatory pathways, and manufacturing operations
Experience working with ISO requirements, GMP guidelines, FDA regulations, and medical device design control processes.
Must have strong analytical and problem solving skills, as well as a good background in the product development process.
Comfortable working with and seeking optimum solutions with multi-disciplinary teams, including engineering, regulatory, clinical, quality, marketing, and manufacturing.
Strong creative ability
| Location: | 751 Miller Drive, SE Suite F-1 Leesburg, VA 20175 United States |
|---|
THIS JOB HAS EXPIRED
K2M
Investors: New Science VenturesAll Jobs: at K2M
| Web Site: | www.k2m.com |
|---|---|
| Headquarters: | 751 Miller Drive, SE Suite F-1 Leesburg, VA 20175 United States |
| Industry: | Medical Devices and Equipment |
