Design Engineer - Customs

Alphatec Spine•Carlsbad, CA

About The Position

Under routine supervision, the Design Engineer is primarily responsible for designing and developing new customized instruments. The work includes ideating design concepts, modeling and creating engineering drawings with 3D CAD software, and performing final inspections of custom devices. The role also involves coordinating with the ATEC machine shop, surgeons, and Sales teams to establish design requirements; managing and tracking multiple requests; and preparing manufacturing work orders. The engineer creates project design documentation, including a Customized Design History File (cDHF), and collaborates on inspection methods. The role may include attending grand rounds, labs, or surgeries to gain clinical experience. Other duties may be assigned.

Requirements

Undergraduate degree in mechanical or biomedical engineering with an emphasis on mechanical design.
1–4 years of product development experience; intern or co-op experience may be applied.
Experience with 3D CAD software, preferably SolidWorks.
Strong verbal and written communication skills, including comfort presenting to senior management.
Must be authorized to work in the United States without current or future employer visa sponsorship.
For roles requiring access to hospital facilities, must be eligible for and maintain credentials at required hospitals, including meeting applicable physical and vaccination requirements.

Nice To Haves

High mechanical aptitude and ability to understand the operation, interaction, and functionality of mechanical systems and devices.
Knowledge of the use and interpretation of geometric dimensioning and tolerancing.
Prior manufacturing-environment experience, including knowledge of manufacturing methods, predominantly involving metals and plastics.
Product development experience in spine or implantable orthopedic medical devices.

Responsibilities

Design and develop customized instruments using SolidWorks.
Intake, track, and complete requests in the ServiceNOW software platform.
Generate project design documentation, including a Customized Design History File (cDHF).
Work with the machine shop on design for manufacturability and assembly (DFM/DFA).
Interface with surgeons, Marketing, and Sales to establish design requirements.
Create and process manufacturing work orders.
Collaborate on the development of inspection methods.
Attend grand rounds, labs, or surgeries to gain clinical experience.
Perform final inspection of custom devices.
Manage and track the status of multiple requests.
Perform other duties as assigned.