About Spinal Elements

Spinal Elements is a Carlsbad, California-based medical device company focused on the design, development, and commercialization of a comprehensive portfolio of systems, products, and technologies for spine surgery procedures. A leading designer, developer, manufacturer, and marketer of innovative medical devices used in spinal surgical procedures, Spinal Elements combines leading medical device technologies, biologics, and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. Spinal Elements has built a reputation delivering innovative and differentiated technologies that enable fundamental shifts in solutions for spine surgery. The company markets a complete portfolio of advanced spinal implant technologies. Learn more at http://www.spinalelements.com/

Meet the Team

The Senior Project Engineer is part of the Engineering Team and reports to the Director of New Product Development. The Engineering team is highly collaborative and works closely with all departments across the organization. Every engineer owns their own project and works closely with every single department in the development of the medical device.

About the role

As a Senior Project Engineer at Spinal Elements, you will design, analyze, and create manufacturing specifications for medical devices in support of spinal surgery including instruments, implants, and packaging. You will conduct feasibility studies and testing on new and modified designs during the product development cycle while working directly with Marketing, Quality, Regulatory Affairs, and Operations. Core responsibilities include:

Design and development of implants and instruments utilizing SolidWorks CAD software.
Leading the development of new products and/or serves as a member of a project team.
Creating working prototype models to be used for project design evaluation.
Testing products to verify the design inputs are met.
Confirming that products meet surgeon and regulatory needs by completing validation and verification activities.
Meeting regularly with surgeons and leads discussions on current projects and providing support in the Operating Room (OR) as needed.
Generating design control documentation for the project Design History File (DHF).
Developing quality control procedures and inspection methods.
Initiates and processes design change orders (CO’s) to improve design and manufacturability.
Leading and/or serving on cross-functional product development teams responsible for new product development from concept through product launch.
Providing technical input to marketing counterparts on the development of collateral marketing materials.
Providing technical expertise to the marketing and sales teams as to design intent.
Providing technical expertise to Regulatory Affairs to support FDA submissions.
Identifying user needs and reducing the user needs into a concept.
Testing and validating the prototypes to recognized standards or develop appropriate performance characteristics.
Completing design control documentation.
Transferring the design to manufacturing by creating concise manufacturing drawings.
Supporting product launch.
Other duties as assigned.

What Makes You Successful

Strong verbal and written communication skills.
Demonstrated mechanical aptitude.
Demonstrated ability to research and fact-check information.
Strong project management leadership skills.
Strong Geometric dimensioning and tolerancing (GD&T) skills.

What You’ll Get (Benefits & Perks)

A full and comprehensive benefits program including medical, dental, vision, short-term and long-term disability, flexible spending accounts, and more
Wellness program and Employee Assistance Program (EAP)
Retirement savings plan (401k) with company match
Travel Assistance Program, Pet Insurance and Legal Services
Educational Assistance Program
15 days PTO
10 paid company holidays and 1 floating holiday
A hybrid work schedule (1 day working remotely)

Experience and Education

Typically requires a BS degree in mechanical or biomedical engineering, with 8+ years related experience, or a Masters degree and 7+ years related experience.
3+ years in the Spine Industry experience required, 5+ years preferred.
Experience using 3D CAD (SOLIDWORKS) to create models and prototypes.
Operating room (OR) experience preferred.

Work Authorization

US Work Authorization required.

Work Environment

This job operates in an office setting.

Travel

These positions require some travel which will be dependent on responsibilities and project load up to 15% of the time.

Spinal Elements is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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Senior Project Engineer