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Project Engineer

Company: Alphatec Spine, Inc.
Location: Carlsbad
Posted on: June 13, 2021

Job Description:

Help us revolutionize the approach to spine surgery!

ATEC Spine is seeking a Project Engineer responsible for development of new products and or the enhancement of existing products in a dynamic start-up environment.

This position will be 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.
  • 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.

QUALIFICATIONS

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 phase gate design control processes
  • Demonstrated success in leading cross-functional product development teams 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 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/or EXPERIENCE

  • Undergraduate degree in mechanical or biomedical engineering, with an emphasis in biomaterials and biomechanics
  • 6-8 years of product development experience in implantable orthopedic medical devices, preferably in spine.

ABOUT ATEC

We are more than a medical technology company. We are a solution-minded, problem-solving organization committed to providing outstanding patient outcomes. ATEC is committed to delivering safe, effective, and innovative products that exceed expectations though our commitment to continuous process improvement and quality excellence. We accomplish this goal by working closely with clinical experts to design and develop systems to effectively and efficiently drive the future of spine surgery. Our innovative platforms focus on simplifying procedures for the surgeon with the ultimate objective of improving clinical outcomes. Our growth is predicated on our ability to innovate and continually develop technologies that will have a significant impact on patient care.

OUR BENEFITS INCLUDE

  • 401k Deferral and Match from Day One
  • Student Loan Repayment
  • Annual Fitness Reimbursement
  • Discounted Healthcare Premiums for Wellness Program Completion
  • Paid Parental Leave
  • Employee Stock Purchase Program

Keywords: Alphatec Spine, Inc., San Diego , Project Engineer, Other , Carlsbad, California

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