Senior Design Engineer

Internetwork Expert; Carlsbad (CA); On-site; USD 85,000 - 95,000; Full time

Job summary

Alphatec Spine, Inc. in California seeks a mechanical/biomedical engineer to design implants and instruments using SolidWorks, lead product development efforts, and create prototype models for evaluation.

The role requires 3–5 years in spine/device development, strong GD&T knowledge, and the ability to present to senior management in a manufacturing environment.

Qualifications

• Bachelor's degree in mechanical or biomedical engineering required.
• 3–5 years product development experience in spine or implantable devices.
• Experience with 3D CAD and SolidWorks in a manufacturing setting.
• Knowledge of GD&T and design for manufacturability.
• Excellent verbal and written communication; ability to present to senior management.

Responsibilities

• Designs, develops and processes implants and instruments using SolidWorks CAD software.
• Leads development of new products and manufacturing processes as part of a project team.
• Directs development of prototype models for design evaluation.
• Manage designers or coops.
• Generate protocols for testing and analysis of products.
• Create Design History File (DHF) documentation.
• Develop quality control procedures and inspection methods.
• Initiate design changes for manufacturability while preserving critical features.
• Lead cross-functional product development teams from concept to launch.
• Provide technical input to marketing on collateral materials.
• Provide technical guidance to marketing and sales on design intent.
• Support FDA 510K submissions with Regulatory Affairs.
• Create and process Engineering Change Orders (ECOs).
• Other duties as assigned.

Skills

3D CAD design

SolidWorks

Phase gate processes

Design for manufacturability

GD&T

Communication

Education

Bachelor's in Mechanical or Biomedical Engineering

Tools

SolidWorks

Job description

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.

• 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