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, develops and processes implants and instruments utilizing Solidworks CAD software.
- 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
- Experience with 3D CAD system, preferably Solidworks
- Experience with phase gate design control processes
- Prior experience in a manufacturing environment, including knowledge of manufacturing methods, predominantly with metals and plastics
- 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 mechanical or biomedical engineering, with an emphasis in biomaterials and biomechanics
- 3-5 years of product development experience, preferably in spine or implantable orthopedic medical devices.
Equal Employment Opportunity & Other Disclosures
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.
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).
At this time, ATEC Spine does not sponsor employment visas for this position. Candidates must be authorized to work in the United States without the need for current or future employer sponsorship.
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. $85,000 - $95,000 Full-Time annual salary
Skills Required
- Experience with 3D CAD systems, specifically SolidWorks
- Experience with phase gate design control processes
- Prior manufacturing environment experience, including metals and plastics
- Knowledge and interpretation of geometric dimensioning and tolerancing (GD&T)
- Strong verbal and written communication skills; comfortable presenting to senior management
- Undergraduate degree in Mechanical or Biomedical Engineering (emphasis in biomaterials and biomechanics)
- 3-5 years product development experience, preferably in spine or implantable orthopedic medical devices
- Experience supporting FDA 510(k) submissions / familiarity with regulatory documentation
- Experience creating and maintaining Design History Files (DHF) and design assurance documentation
- Experience creating and processing Engineering Change Orders (ECOs)
What We Do
ATEC Spine is a medical device company dedicated to revolutionizing the approach to spine surgery through innovation. ATEC’s Organic Innovation Machine™ is the greatest concentration of spine know-how in the industry and committed to the creation of clinical distinction. Leveraging 100% spine focus and expertise, we seek to improve spine surgery by rethinking, redesigning and seamlessly integrating the technologies required from the ground up. The innovation that results from that process is being rapidly adopted because, like us, spine surgeons covet informatic and procedural sophistication that enables more predictable, more reproducible care. Our flagship technology, the Prone TransPsoas (PTP™) Procedure, leveraged decades of experience to advance first-generation lateral surgery with a more familiar patient position and elevated neuromonitoring. EOS imaging, the backbone of ATEC’s informatic ecosystem, provides radiographic imaging, enabling standing, full-body, global alignment assessments. We are further developing EOS technology to elevate spine care with unprecedented capabilities. Our vision is to be the standard bearer in spine. Visit our website for more information: www.atecspine.com
