Toro Neurovascular · 13 hours ago
Senior Research And Development Engineer
Irvine, CA
Full-time
Onsite
Senior Level
3+ years expToro Neurovascular is seeking a Principal Research & Development Engineer responsible for designing, developing, and qualifying innovative technologies for acute ischemic stroke. The role involves managing projects, interfacing with cross-functional teams, and ensuring compliance with quality management systems from concept to commercialization.
ManufacturingMedicalMedical Device
Responsibilities
Actualize new designs for new products and build a strong intellectual property portfolio together with the team
Execute project plans and support accountability for achieving timely completion of various phases of the project
Contribute to design history file including risk analysis, design verification and validation testing, test method validations as well as other design control documents, and phase gate reviews associated with the development process
Work with vendors/partners for sourcing components, developing prototypes, assemblies or sub-assemblies and related processes for components or assemblies, selecting the best vendors/partners in consultation with the team and managing external partners or vendors to ensure timely and cost-effective completion of tasks
Identify and procure process/prototyping equipment as needed to conduct product development per the company strategy
Work with physician advisors, sales, and customers; support specification development for the product to serve these unmet clinical needs and ensure that design outputs meet design inputs through the design control process
Ensure that the designs are manufacturable; and that manufacturability is given due consideration during the design process from the early stages onwards. Ensure that the processes are developed and validated per the company procedures and processes are scalable to the desired volumes in an acceptable time-period
Support design verification and validation in collaboration with regulatory and other cross functional teams to meet regulatory approvals for medical devices in chosen geographies including, but not limited to, the US
Participate in formulating a long-term strategy with respect to new and emerging technologies that advance company objectives
Qualification
Required
A bachelor's or master's degree in mechanical, biomedical, or materials Engineering or related field
Minimum 3 years' experience in medical device product development on Class II and Class III devices
Expert level knowledge of medical device product development processes including risk management and exposure to FDA regulations
Strong verbal and written communications with ability to effectively communicate within the organization, external vendors, and partners
Knowledge of test standards applicable to endovascular medical devices
Familiar with statistical methods used in design, process, and use risk analysis as well as sample size calculations for design verification and being conversant in analyzing test data and optimizing processes
Company
Toro Neurovascular
Toro Neurovascular develops neurovascular medical devices for treating strokes.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Marc Paris
Chief Commercial Officer
Recent News
2025-10-10
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