LEAD MECHANICAL ENGINEER

Nia Therapeutics is developing brain stimulation devices to restore memory function after brain injury and degenerative disease. Our team includes leaders in the fields of engineering, cybersecurity, neuroscience, and neurosurgery, and our core technology has the potential to revolutionize the treatment of patients with memory loss. We are looking for a Lead Mechanical Engineer to work in our Boston, MA office.

The Lead Mechanical Engineer position is responsible for leading the design, development, and testing of mechanical systems and components for our neurotechnology products. This role requires a strong foundation in mechanical engineering principles and the ability to apply them to solve complex engineering problems. You will be responsible for leading all aspects of mechanical engineering product development, from concept brainstorming through transfer to manufacturing and commercialization.

RESPONSIBILITIES

Lead mechanical engineering activities for all product development initiatives.
Design and develop mechanical systems and components to meet project objectives.
Define and determine product specifications and user needs.
Collaborate with cross-functional teams to perform system-level integration with larger systems.
Transfer designs to manufacturing partners and qualify manufacturing processes.
Analyze risks associated with mechanical components and subassemblies and propose mitigation strategies.
Conduct analysis and testing to ensure the reliability, safety and performance of mechanical designs.
Develop automated test systems for design verification testing.
Provide technical support and troubleshooting for mechanical systems.

EDUCATION AND EXPERIENCE

Bachelor’s degree in mechanical engineering AND 5+ years in relevant device development OR master’s degree in mechanical engineering AND 2+ years in relevant device development.
Proficiency with CAD modeling tools (e.g. SolidWorks).
Experience working through a complete concept-to-manufacturing product lifecycle.
Experience integrating PCBs and electronic subassemblies into mechanical designs.
Experience with new product development and design for manufacturability.
Experience with risk analysis (e.g. FMEA).
Experience with statistical techniques and tolerance stack-up analysis.
Experience executing Reliability Verification testing for electro-mechanical medical devices.
Experience designing, executing and documenting Design Verification testing for medical devices.
Experience with manufacturing methods such as injection molding, fixturing, machining, and laser welding.
Excellent organizational, communication and teamwork abilities.
Strong analytical and problem-solving skills.

PREFERRED

Experience developing neurotechnology products.
Experience developing Class III active implantable devices (ISO-14708, ISO-13485).
Experience selecting materials for implantable devices (ISO-10993).
Experience working with and managing contract manufacturing partners.
Collaborate with in-house regulatory team to develop regulatory submissions.

LOCATION

This position is based at our Boston office. We utilize a hybrid schedule requiring four in-office days per week. Must be eligible to work in the US.

TRAVEL

Up to 10% domestic travel required.