Project Engineer, Advanced Technology

Directly responsible for the development of new products and or the enhancement of existing products associated with Electromechanical technology platforms. 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. Generate protocols for testing new and current products. Develop quality control procedures and inspection methods and provide technical expertise in support of FDA 510K submissions.

Essential Duties and Responsibilities

• Independently responsible for the design, development, and processing of new medical products with integrated electro-mechanical and software technology, as well as related procedures and instruments utilizing Solidworks CAD software.
• Leads the development of new products and manufacturing processes and/or serves as a key member of a project team. Supports transfer of designs to external manufacturers
• Responsible for the development of prototype models for evaluation by design surgeons.
• Establishes protocols for testing and analyzing new and current products.
• Generates design assurance documentation for the project Design History File (DHF).
• Provides support to current products manufactured in house or by outside vendors
• Assisting Regulatory, by providing necessary documentation for FDA submissions. Provides engineering support to Manufacturing, Quality Control, Marketing, and Sales as necessary
• Provides technical input to marketing counterparts on the development of collateral marketing materials
• Creates and processes Engineering Change Orders (ECO's)
• Develops quality control procedures and inspection methods
• 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 system, preferably Solidworks
• Experience with designing mechanical enclosures, mechanisms, and electromechanical assemblies
• Demonstrated success in leading product development from concept through product launch, including demonstrated planning, organizing and time management skills
• Prior experience in a manufacturing environment, including knowledge of manufacturing methods, predominantly with machining metals and injection molding plastics
• Strong knowledge of drawing best practices and in the use and interpretation of geometric dimensioning and tolerancing
• Must be detail oriented, an effective communicator, and able to work within a team environment
• Strong verbal and written communication skills; comfortable presenting to senior management

Education and Experience

• Minimum Bachelor's degree from four-year College or university in Mechanical or Biomedical Engineering.
• Minimum of 4-6 years years experience.
• Must have a minimum of 2 in medical device product development environment. Would prefer experience be in Spine or Orthopedics.

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. $95,000 to $120,000 Full-Time Annual Salary