About the Company:
CereVasc is a clinical stage, medical device company focused on the development of novel, minimally invasive treatments for patients with neurological diseases. The Company’s first product, the eShunt® System, has been developed to treat communicating hydrocephalus (“CH”), a potentially life-threatening disease also known as “water on the brain”. The eShunt device has the potential to disrupt a 60-year-old standard of care characterized with high failure and complication rates that typically result in patients requiring multiple revision surgeries over the span of their treatment.
Developed by two world-renowned neurosurgeons at Tufts Medical Center, the eShunt System includes a permanent implant delivered endovascularly and has been designed to avoid invasive surgery, extended hospitalization, and post-procedure pain management typically associated with the current surgical treatment of CH with conventional shunt devices. The eShunt System will address a $5 billion market opportunity with a novel alternative to conventional treatments and has the potential of positively impacting the lives of more than 400,000 CH patients in the US and EU. The eShunt technology platform has potential for expansion into other disease states including treatment for idiopathic intracranial hypertension and minimally invasive delivery of therapeutic agents to the intracranial subarachnoid space.
CereVasc is currently managing a first-in-human clinical trial of the eShunt System and in January 2022 will complete an IDE submission for the Company’s first US clinical trial of the eShunt device.
About the position:
The Head of Product Development will report to the SVP Operations and lead new product development initiatives at the Company including product improvement efforts. The Head of Product Development will be responsible for developing, with senior management, the Company’s overall strategic goals, project cadence, product portfolio, and integrated business plans. She/He takes a leadership role ensuring that product development initiatives support the overall business strategy, meet quality and regulatory requirements, and transfer to manufacturing successfully. The Head of Product Development will develop, grow, and manage the engineering organization, including contract development partners and key suppliers, to drive products from concept through clinical trials to commercialization. She/He will develop engineering plans and budgets, and ensure that approved plans are executed on time, within quality guidelines, and within budget. The Head of Product Development provides strategic input on regulatory, quality, product and manufacturing strategies and is considered a key leader on all aspects of product development and manufacturing operations.
- Manages product development projects in close collaboration with Quality/Regulatory/Clinical team members
- Provides input to regulatory strategy for all development projects, anticipating changes in regulatory environment and approval requirements (in view of product registration)
- In collaboration with the affiliated contract developers and contract manufacturers, provides leadership in the design and construct of a development plan to ensure proper product registration supports corporate goals
- Defines the design and development plan of all Company product development projects in accordance with current regulatory and quality assurance (i.e., design control) guidelines
- Ensures implementation of formal processes to support the product development process (e.g., systematic design and technical reviews)
- Participates in meetings with health authorities as appropriate
- Manages project schedules and milestones to ensure timely product launch within approved budgets
- Identifies and implements product improvements to optimize performance and availability of unique materials
Preferred Qualifications and Experience:
- Minimum 4-year Bachelor’s Degree in an engineering or life science field from accredited college or university
- Advanced degree (MS, PhD, etc.) desirable
- Minimum 7 years of experience in product development and manufacturing in the medical device industry; experience with Class III medical devices preferred
- Experience in mechanical engineering, medical device manufacturing, materials for medical devices, plastic and metal processing, and clean room assembly
- Experience developing interventional neurovascular, peripheral vascular or cardiovascular devices preferred
- Strong knowledge of FDA regulations, guidelines, and European regulatory processes
- Strong knowledge of governmental requirement practice (GMP, GCP, GLP, GVP, ISO) and other international clinical, regulatory requirements
- Strong analytical and problem-solving skills, with a demonstrated knowledge of statistical analysis techniques
- Positive, self-motivated, detailed, and hands-on, with the ability to work independently as well as collaboratively in a dynamic start-up environment
Interested in learning more? 180one is a retained search firm engaged by CereVasc to conduct this search. If interested in learning more about the opportunity, please contact Lisa Heffernan at 180one at 971.256.3076 or email@example.com.
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