**Senior Mechanical Engineer Role Summary**
We are seeking an experienced Senior Mechanical Engineer to join our product development team. As a key member of the team, you will be responsible for designing, developing, and implementing medical devices for electrical spinal cord stimulation.
The successful candidate will have a strong background in mechanical engineering, with experience in sterile implantable and/or surgical medical devices. They will also possess excellent manufacturing techniques relevant for complex electromechanical medical devices, including welding, casting, molding, bonding, machining, and extrusion.
We are looking for a self-motivated individual who can work well in a strictly regulated environment, where product development is subject to quality system standards such as ISO 13485. The ideal candidate will have a solid understanding of System Risk Management and the principles of Design for Manufacturing, Assembly and Testing.
About the Job
* Serve as Subject Matter Expert (SME) on materials and manufacturing processes specific to active implantable medical devices (AIMDs).
* Ensure compliance with and drive certification to standards applicable to AIMDs, such as ISO 11607-1 & -2, ISO 11737-1 & -3, ISO 11135, AAMI ST72, ISO 10993, EN 45502, and ISO 13485.
* Lead technical supplier management and oversee project execution for designated product(s).
* Create feasibility concepts, designs, and processes that meet requirements.
* Lead Design Verification and Process Validation activities for assigned product(s).
About You
* Bachelor's, master's, or PhD degree in mechanical engineering or equivalent.
* Relevant industry experience in sterile implantable and/or surgical medical devices.
* Experience with manufacturing techniques relevant for complex electromechanical medical devices, including welding, casting, molding, bonding, machining, and extrusion.
* Experience developing and certifying products compliant to ISO 14708 standards or other similar highly regulated industry relevant international and/or company standards (ISO, ASTM, AAMI, IEC, etc).
* Solid mechanical design experience, with hands-on experience in relevant 2D/3D CAD design and mechanical FEM modeling tools.