Job Summary:

The Principal Research & Development Engineer will be responsible for designing, developing, and qualifying innovative technologies to serve unmet clinical needs in acute ischemic stroke. This position will interface with the cross-functional team members and manage external vendors and partners to drive timely and cost-effective completion of projects compliant with the Company’s quality management system, while driving the execution of product development projects from concept to commercialization.

Role & Responsibilities:

· Conceive new designs for new products and build a strong intellectual property portfolio together with the team.

· Develop project plans including timelines, resources, Gantt charts and be accountable for achieving timely completion of various phases of the project.

· Be responsible for design history file including risk analysis, design verification and validation testing, test method validations well as other design-control documents, and phase gate reviews associated with the development process.

· Manage cross-functional team to execute product development projects.

· Identify potential 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.

· Articulate unmet clinical needs in collaboration with physician advisors, sales, and customers; develop specifications 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.

· Develop design verification and validation strategy and protocol 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, Skills and Experience:

· A bachelor’s or master’s degree in mechanical, biomedical, or materials Engineering or related field

· Minimum 8 years’ experience in medical device product development on Class II and Class III devices.

· Minimum 5 years of experience in R&D function in medical devices

· Experience with neurovascular catheter design and/or, development

· A track record of creating innovative medical device designs, which were brought to market successfully.

· 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.

· Demonstrated ability to execute product development plans to meet company’s goals in a timely manner.

Please note: We are not working with recruiters or recruitment agencies for this position. We are only considering applications submitted directly by candidates. Thank you for your understanding.