Design Engineer – 3D Printing Specialist– Medical Device

Nexxt Spine • Noblesville, IN

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About The Position

Design Engineer – 3D Printing Specialist– Medical Device Nexxt Spine LLC, Noblesville, IN Nexxt Spine LLC, is a leader in the medical device industry, dedicated to designing, manufacturing, and distributing an expanding portfolio of innovative spinal implants and instruments. We are committed to a culture of innovation, excellence, and employee engagement while delivering solutions that improve patient outcomes and strengthen surgeon and distributor partnerships. JOB DESCRIPTION Design and develop spinal implants and instruments starting with surgeon meetings on initial concepts, creating prototypes using SolidWorks, 3D printing, SLA or machining equipment, securing patents, FDA testing and 510(k) clearance, documenting DHFs, and ultimately delivery to the market.

Requirements

• Extensive experience with 3D design, additive manufacturing, and associated tools.
• Extensive experience in end-to-end 3D printing workflows, including printer calibration, build preparation, post-processing (curing, sintering, machining), and inspection.
• Experience in patient specific design automation and subsequent workflow.
• Proficiency in converting CT, MRI, and CBCT scans into 3D anatomical models.
• Experience with DCOM segmentation tools.
• Understanding of material properties and the application of mathematics and dimensions to models and drawings.
• Must be a critical thinker, using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to new opportunities.
• Must be capable of creative problem solving, able to create novel solutions to the challenges of modern manufacturing.
• Basic knowledge of FDA, GMP, & ISO requirements.
• Must be self-motivated.
• Must be able to efficiently integrate existing methods with new innovations and communicate effectively at all levels.
• Bachelor of Science Degree in Engineering
• Experience as a Design/Project Engineer of spinal implant medical devices is preferred.

Nice To Haves

• Experience with modeling and simulations using SolidWorks is beneficial.
• Experience in traditional manufacturing and laboratory research is a plus

Responsibilities

• Design spinal implants using SolidWorks or equivalent
• Create complex 3D printed geometry using Additive Manufacturing Software
• Collaborate with manufacturing to prototype and implement full-scale production of products
• Maintain accurate information on processes and materials used to develop new products
• Manage project timelines for all implants and instruments
• Responsible for new product introduction from conceptual design review with surgeons through regulatory clearance and into production
• Manage the mechanical and related testing requirements for FDA submission

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level