Company: Alphatec Spine, Inc.
Posted on: June 13, 2021
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
- 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
- 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.
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
- 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.
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
OUR BENEFITS INCLUDE
- 401k Deferral and Match from Day One
- Student Loan Repayment
- Annual Fitness Reimbursement
- Discounted Healthcare Premiums for Wellness Program
- Paid Parental Leave
- Employee Stock Purchase Program
Keywords: Alphatec Spine, Inc., San Diego , Project Engineer, Other , Carlsbad, California
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