Sr. Project Engineer, Advanced Technology

Directly responsible for the development of new products and or the enhancement of existing products associated Alpha InformatixTM adjunctive technology and electro-mechanical technology platforms. Lead or serve as a member of a project team involved in creating mechanical designs that support complex products combining mechanical, electrical and software elementsOther 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

• 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.
• Leads the development of new products and manufacturing processes and/or serves as a key member of a project team.
• Responsible for the designing and developing of new products utilizing Solidworks CAD software.
• Responsible for the development of prototype models for evaluation by design surgeons.
• Responsible for the assurance documentation for the projects.
• Provides support to current products manufactured in house or by outside vendors
• Facilitates new projects from concept through production.
• Assisting Regulatory, by providing necessary documentation for FDA submissions. Provides engineering support to Manufacturing, Quality Control, Marketing, and Sales as necessary
• 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.

• Demonstrated success in leading product development from concept through product launch, including demonstrated planning, organizing and time management skills
• Experience with 3D CAD systems, preferably Solidworks,
• Experience in product design procedures and project development methodology in the medical device industry, with general knowledge of device testing.
• Experience with mechanical systems, which also include electrical and software components.
• Experience of manufacturing methods including machining, sheet metal, injection molding and electronic device manufacturing. Experience in sterile disposable devices a plus.
• Experience in the use and interpretation of GD&T and completing complex tolerance analysis.
• Strong verbal and written communication skills; comfortable presenting to senior management
• Solid experience in working on project teams with successful completion.
• Ability mentor junior engineers

Education and Experience

• Minimum Bachelor's degree from four-year College or university in Mechanical or Biomedical Engineering, Masters preferred.
• 7-10 years industry experience. Must have a minimum of 2 in medical device product development environment. Would prefer experience be in Spine or Orthopedics.

Certificates, Licenses, Registrations

• Solidworks Certification preferred
• GD&T Certification preferred

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. $115,000 to $160,000 Full-Time Annual Salary