Project Engineer

at  Spinal Elements

Typically, an Undergraduate degree in mechanical or biomedical engineering, with an emphasis in biomaterials and biomechanics with 6-8 years related work experience or equivalent. Some post graduate work may have been completed or they may have a MA or MS in a directly related field with five or more years of product development specific to implantable orthopedic medical devices, preferably in spine. Works on problems of diverse scope where analysis of information requires evaluation of identifiable factors. Complete knowledge and full understanding of area of specialization, principles and practices within a professional discipline. Assesses unusual circumstances and uses sophisticated analytical and problem-solving techniques to identify the cause. Resolves and assesses a wide range of issues in creative ways and suggests variations in approach. Must have prior experience developing complex instrumentation, either developing a complex instrumentation system or leading project activities related to a TLIF or ALIF system. Continues to assume responsibilities and solve problems with a diverse scope with little or no general direction. Direction on new assignments would be provided as well as project kickoff and design review cycles. May require a mentorship role with an entry-level engineer or engineering intern.

KNOWLEDGE, SKILLS, AND ABILITIES (KSA):

The Project Engineer must possess the following skills and demonstrate increasing proficiency in each area throughout their career development.

• Strong verbal and written communication skills
• Demonstrated mechanical aptitude
• The ability to research and fact check information
• Work with Marketing & customers to identify user needs and translate the user needs into initial conceptual designs/prototypes.
• Use 3D CAD (SOLIDWORKS) to create models and prototypes
• Test and validate the devices to recognized standards or develop appropriate performance characteristics
• Strong understanding of Design Controls
• Transfer the design to manufacturing by creating concise manufacturing drawings
• Prior complex instrumentation development experience or leading project activities related to a TLIF or ALIF system
• Strong design for manufacturability knowledge
• Support product launch

CORE JOB RESPONSIBILITIES:

The Project Engineer at Spinal Elements, designs, analyzes, and creates manufacturing specifications for medical devices in support of spinal surgery including instruments, implants, and packaging. They 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.

ESSENTIAL FUNCTIONS:

• Designs and develops implants and instruments utilizing SolidWorks CAD software.
• Leads the development of new products and/or serves as a member of a project team.
• Creates working prototype models to be used for project design evaluation.
• Tests products to verify the design inputs are met.
• Confirms products meet surgeon and regulatory needs by completing validation and verification activities.
• Generates design control documentation for the project Design History File (DHF).
• Develops quality control procedures and inspection methods.
• Initiates and processes design change orders (COs) to improve design and manufacturability.
• 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 design intent.
• Provides technical expertise to Regulatory Affairs to support FDA submissions.
• Other duties as assigned.
  Work Authorization US Work Authorization required
  Work Environment This job operates in an office setting.
  Physical Demands While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus. The employee will be required to attend surgeries, manufacturing facilities, and conferences which may require standing for extended periods of time.
  Travel These positions require some travel which will be dependent on responsibilities and project load up to 15% of the time