Senior Design Engineer, Biologics

Under routine supervision, primarily responsible for the development of new products and or the enhancement of existing products. Lead or serve as a member of a project team. Involved in creating designs, modeling and drafting utilizing a 3D CAD system. Other responsibilities include assisting in the development processes for Manufacturing, Quality Control, Regulatory and Planning for their particular project.

Essential Duties and Responsibilities

• Designs and develops biologics products from concept to full launch
• Leads the development of new products and manufacturing processes and/or serves as a member of a project team
• Directs the development of working prototype models to be used for project design evaluation
• Manage designers or coops
• Generates protocols for testing and analyzing new and current products
• Generates design assurance documentation for the project Design History File (DHF)
• Develops quality control procedures and inspection methods
• Initiates design changes relative to manufacturability while maintaining critical features of each product for in house manufacturing or vendors
• Leads and/or serves on cross-functional product development teams responsible for new product development from concept through product launch
• Provides technical input to marketing counterparts on the development of collateral marketing materials
• Provides technical expertise to marketing and sales as to intent of design function
• Provides technical experience to Regulatory Affairs to support FDA 510K submissions
• Creates and processes Engineering Change Orders (ECO’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 phase gate design control processes
• Prior experience in a manufacturing environment, including knowledge of manufacturing methods, predominantly with metals and plastics
• Experience with 3D CAD system, preferably Solidworks (not a requirement)
• Knowledge in the use and interpretation of geometric dimensioning and tolerancing
• Strong verbal and written communication skills; comfortable presenting to senior management

Education and Experience

• Undergraduate degree in biomedical engineering, with an emphasis in biomaterials
• 3-5 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. $90,000 to $95,000 Full-Time Annual Salary.