Product Development Engineer
About the Job:
SpineCraft develops and manufactures spine surgery implants & instruments systems that provide comprehensive spine care solutions to improve and enhance quality of life for patients with back pain, neck pain, degenerative disc conditions, spine deformities and injuries due to trauma.
We are looking for experienced product development engineer to join our growing R&D team.
PRIMARY FUNCTIONS & RESPONSIBILITIES:
- Under limited guidance, will perform highly complex engineering duties associated with the design and development of spine implant and instrument systems.
- Responsible for different research & development activities that could involve multiple interfaces internal and external to the company.
- Interface with surgeons to develop user requirements and evaluate designs.
- Review and approve both implant and instrument designs and drawings.
- Control and implementation of Product Development process, including Project Planning, FMEAs, Design Reviews, DHF creation & maintenance, etc.
- Research, analyze and create intellectual property.
- Interface with various vendors to manufacture prototypes and finished devices.
EXPERIENCE & SKILL REQUIREMENTS:
- Must have proven comprehensive experience in spine instrumentation product development.
- Should have working understanding of FDA QSR, MDD and ISO-13485 principles.
- Should be a self-motivated individual that is able to work with limited supervision.
- Ability to conduct theoretical analysis and develop mechanical test protocols of different spine implant types.
- Commanding knowledge of 3D CAD systems (SolidWorks preferred).
- Working knowledge of manufacturing processes and capabilities.
M.S. Mechanical Engineering and at least 5 years’ experience including minimum 3 years’ spine instrumentation development experience.
SpineCraft offers a generous compensation and benefits package that includes comprehensive medical, dental, and vision insurance benefits plus a 401K retirement plan.