VP, R&D (Neurovascular) - #1410885
Terumo Neuro
Date: 6 hours ago
City: Aliso Viejo, CA
Contract type: Full time
Job Description
Oversee the organization’s design and development of new products and processes, product changes and enhancements, while collaborating closely with Marketing, Sales, Regulatory, Quality, Operations, Finance, and Clinical teams to support organizational growth and strategic goals. Job duties:
US - United States
Oversee the organization’s design and development of new products and processes, product changes and enhancements, while collaborating closely with Marketing, Sales, Regulatory, Quality, Operations, Finance, and Clinical teams to support organizational growth and strategic goals. Job duties:
- Oversee all aspects of global product development, process development, and design control from product inception to process validation and provide support throughout the product lifecycle.
- Identify short- and long-range global product strategies and new technologies.
- Ensure the accuracy and complete records of product development activities and the assurance of meeting regulatory requirements and compliance to the Quality Management System (QMS).
- Responsible for New Product Development (NPD) teams to develop accurate and aggressive project schedules incorporating all information and experience available and ensure strict adherence and accountability to project schedules while meeting the customer and/or marketing requirements.
- Work and collaborate with an Enterprise mindset with all cross-functional departments and Executive Staff, mitigating cross-functional conflict to find solutions to challenges and lead when necessary.
- Develop and nurture strong collaborative and mutually beneficial relationships with Operations, Quality, Regulatory, and Marketing to ensure transparent and accurate communications toward seamless transitions and mutual support from ideation to NPD to production transfer and through the product life cycle.
- Work with Business Development (Bus-Dev) to evaluate technical feasibility of potential acquisitions.
- Generate and support generation of intellectual property.
- Represent the Company with key opinion leaders (KOLs) in the treatment of various diseases to better understand new product needs and evaluation of R&D technology, prototypes, and products.
- Attend global business development opportunities for observation of pre-clinical and clinical cases, attendance in relevant conferences and meetings, and engaging with physicians.
- Develop and monitor labor, projects, and capital expenditure budgets.
- Hire, train, and develop high performing staff/leaders and promote a culture of innovation, ownership, and a can-do attitude.
- Propose, develop, support, recommend, and drive changes to the QMS and other procedures, systems, and processes of the Company to better meet corporate objectives.
- Propose, plan, support, and/or perform domestic and international FIH and clinical and pre-clinical studies.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform additional duties as assigned.
- Bachelor of Science in Mechanical Engineering or related/equivalent field of study.
- A minimum of twenty (20) years of relevant professional experience in a medical device environment with experience in endovascular procedures.
- A minimum of ten (10) years of increasing management or leadership experience.
- Demonstrated experience working in a global environment with multi-country responsibility.
- Knowledge of US and foreign regulations relative to the design and manufacture of medical devices.
- Knowledge and proficient experience in products, product development, processes and process development of medical devices, and specifically disposable medical devices.
- Excellent written and verbal communication skills, including outstanding interpersonal and collaborative skills and high emotional intelligence.
- Ability to manage and lead effectively to achieve department and corporate goals while fostering a healthy and positive work environment.
- Strong business and global acumen.
- Proficient with MS Word, Excel, Outlook, and Teams.
- Advanced degree in Science or Engineering.
- Knowledge of medical, engineering, and biomedical development.
- Knowledge of quality system and other standards in the industry.
- Ability to read and prepare technical documentation.
- Knowledge of the clinical procedures in interventional neuroradiology.
US - United States
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