Under routine supervision, primarily responsible for the development of new products and/or the enhancement of existing products associated with Electromechanical technology platforms. Responsibilities include development of processes and bringing up Manufacturing, development of test plans to assess designs, drafting of design history file documents, and assisting in the Quality Control and Regulatory documentation. Also involved in creating concepts and modeling and drafting designs utilizing 3D CAD software.
Essential Duties And Responsibilities

• Designs, develops new products and manufacturing processes of new medical devices with integrated electro-mechanical and software technology
• Plan and executes experiments (DOEs) to demonstrate design, machine and process capability and repeatability. Identifies and inputs variables and critical process parameters.
• Generates protocols for testing and analyzing new and current products & processes
• Initiates new manufacturing processes with external vendors
• Initiates design changes relative to manufacturability while maintaining critical features for in house manufacturing or vendors
• Develops working models to be used for design evaluation and prepares drawings for manufacturing utilizing SolidWorks. Works to access future field reliability of designs
• Generates design assurance documentation for the project Design History File (DHF)
• Develops quality control procedures and inspection methods.
• Leads and/or serves on cross-functional product development teams responsible for new product development from concept through product launch
• Creates and processes Engineering Change Orders (ECO's)
• Other duties as assigned.

RequirementsThe 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 new process development and early manufacturing bring up. Use of statistic, DOE's and 6 sigma techniques. MiniTab or JMP
• Experience with 3D CAD software, preferably SolidWorks
• Experience with phase gate design control processes
• Prior experience in a manufacturing environment, including knowledge of manufacturing methods, predominantly with metals and injection molded plastics, preferred
• Strong verbal and written communication skills; comfortable presenting to senior management
• Ability to work independently

Education And Experience

• Undergraduate degree in mechanical or biomedical engineering
• 3-5 years of product and process development experience, preferably in 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 RangeAlphatec 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. $82,000 to $110,000 Full-Time Annual Salary