Design Engineer – 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.
ESSENTIAL DUTIES AND RESPONSIBLITIES
- Responsible for new product introduction from conceptual design review with surgeons through regulatory clearance and into production
- Design spinal implants using SolidWorks or equivalent
- Create complex 3D printed geometry using Additive Manufacturing Software
- Manage project timelines for all implants and instruments
- Coordinate with legal for patents
- Manage the mechanical and related testing requirements for FDA submission
- Collaborate with manufacturing to prototype and implement full-scale production of products
- Maintain accurate information on processes and materials used to develop new products
QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required;
- Must have a skill set to design implants and/or instruments. Should understand properties of materials 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 beneficial
- Must be able to efficiently integrate existing methods with new innovations and communicate effectively at all levels
- Experience with modeling and simulations using SolidWorks is beneficial
- Experience with additive manufacturing is beneficial
- Experience in traditional manufacturing and laboratory research is a plus
EDUCATION and/or EXPERIENCE
- Bachelor of Science Degree in Engineering
- Experience as a Design/Project Engineer of spinal implant medical devices is preferred.
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
