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$75,000-90,000/year
Alphatec Spine
Carlsbad, CA, USA
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ShareUnder routine supervision, primarily responsible for the enhancement of existing products on our sustaining team. Involved in creating concepts and modeling and drafting designs utilizing 3D CAD software. Other responsibilities include drafting of design history file documents, development of test plans to assess designs, and assisting in the development processes for Manufacturing, Quality Control, Regulatory and Planning for their particular project. Essential Duties and Responsibilities Designs and develops implants and instruments utilizing SolidWorks. Assists in the development of new products and manufacturing processes and/or serves as a member of a development team. Assists in the development of working models to be used for design evaluation. Generates protocols for testing and analyzing new and current products. Generates design assurance documentation for the project Design History File (DHF). Collaborates on the development of inspection methods Initiates design changes relative to manufacturability while maintaining critical features for in house manufacturing or vendors Serves on cross-functional product development teams responsible for new product development from concept through product launch. Assists Project Engineers with providing technical input to marketing counterparts on the development of collateral marketing materials Assists Project Engineers with providing technical expertise to Marketing and Sales as to intent of design function. Assists Project Engineers with providing technical expertise to Regulatory Affairs to support FDA 510(k) submissions and/or international registrations. Creates and processes Change Orders (CO’s) Other duties as assigned. Requirements The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Experience with 3D CAD software, preferably SolidWorks Strong verbal and written communication skills; comfortable presenting to senior management Knowledge in the use and interpretation of geometric dimensioning and tolerancing, preferred Prior experience in a manufacturing environment, including knowledge of manufacturing methods, predominantly with metals and plastics, preferred. Education and Experience Undergraduate degree in mechanical or biomedical engineering, with an emphasis in biomaterials and biomechanics 1-4 years of product development experience, preferably in spine or implantable orthopedic medical devices. For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable). ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws. Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate’s qualifications, education, skill set, years of experience, and internal equity. $75,000 to $90,000 Full-Time Annual Salary
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Detroit, MI, USA