Senior Mechanical Engineer
hace 1 mes
**Job Title:** Senior Mechanical Engineer (Medical Devices Expert)
**Job Summary:** We are seeking a skilled Senior Mechanical Engineer with experience in medical devices to join our team at Inbrain Neuroelectronics. As a Senior Mechanical Engineer, you will contribute to the design, development, and testing of mechanical systems for our CNS neuromodulation implant and its peripheral equipment.
**Key Responsibilities:**
* Lead the design, assembly, prototyping, and testing of mechanical components for an implantable CNS neuromodulation system.
* Collaborate with electronics, systems, quality, and regulatory teams to ensure compliance with CE mark and FDA approval requirements.
* Work with clinicians, users, and other team members to define and evolve requirements and guidelines for mechanical component design.
* Design for reliability, manufacture, and test, including concept engineering, functional analysis, FEM analysis, and mechanical modeling.
* Deliver detailed documentation of device design (BOM, drawings, specifications, test plan) compliant with ISO 13485 and ISO 14971 design control requirements.
* Support and collaborate with external partners in the outsourced design, assembly, and testing of mechanical components.
* Qualify, validate, and create maintenance plans for lab tools and equipment.
* Define test plans and methods to verify safety and mechanical performance of the device, in compliance with applicable standards.
**Requirements:**
* BS or MS in Mechanical Engineering with at least 5 years of work experience in a relevant industrial setting (regulated environment, MedTech is a strong plus).
* Proven experience executing a full development cycle.
* Experience in developing multidisciplinary medical devices is a plus.
* Minimum of 2 years of leading technically oriented teams.
**What We Offer:**
* Competitive salary and benefits package.
* Opportunity to work on cutting-edge medical devices.
* Collaborative and dynamic work environment.
* Professional development and growth opportunities.
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