Sunnyvale, California

Location: Sunnyvale, CA or Minneapolis, MN

Summary:

Silk Road Medical is looking for a Director of R&D for the Pipeline and Innovation Team. This person will oversee early stage learning and execution of product development projects in support of company’s strategic plan, including development of long-term goals and short-term tactics. Manage staff and outside resources assigned to development project(s). Responsible for approval, initiation, and management of development projects. Develop external and cross-functional relationships in execution of product development goals. Develop clinical and market research knowledge base in project areas to support R&D efforts and develop customer requirements and product specifications.

Essential Job Functions:

  • Partner with physicians, upstream marketing and OMA to define unmet clinical need.
  • Participate in setting company product development strategy.
  • Direct R&D activities, employees, outside consultants, and support other departments to develop new products aligned with the strategic direction of the organization.
  • Facilitate development through definition of unmet need, specification development, prototyping, and in vitro and vivo evaluation, and clinical feedback.
  • Support Clinical Affairs in the clinical evaluation and training of new and existing products.
  • Evaluate new product and procedure opportunities through Company employee, advisor, and outside clinical input through literature, conferences, and other Clinical & Marketing information sources.
  • Support all company functions as needed, including R&D, Operations, Quality, Clinical and Regulatory.
  • Support the continual improvement of the company’s quality systems, product development process and design controls.
  • Support the development and upkeep of the Company’s quality system in conjunction with the Company’s Quality Affairs Department.
  • Accomplishes financial objectives by forecasting requirements; preparing and maintaining an annual budget.
  • Accomplishes staff results by communicating job expectations, planning, monitoring including staff development and training.
  • Actively promote and lead organization to adhere to SRM Employment/Safety policies and procedures.

Requirements:

  • BS Degree in the Engineering or Technical Field; advanced degree highly preferred.
  • Minimum of 12 years of related experience in the industry.
  • 5+ years of experience in the direct management of medical device product development team.
  • Must have business knowledge, leadership skills and product/process development capabilities.
  • Excellent communication, personnel (staff) management, and time management skills.
  • Significant experience working directly with healthcare providers to define unmet need.
  • Extensive knowledge of company products and business strategy.
  • Project management experience a plus.

Will you join us?

Sunnyvale, California

Silk Road Medical, Inc. is a medical device company located in Sunnyvale, California, that is focused on reducing the risk of stroke and its devastating impact. The company has pioneered a new approach for the treatment of carotid artery disease called TransCarotid Artery Revascularization (TCAR). TCAR is a clinically proven procedure combining surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke. For more information on the company, visit our website at http://silkroadmed.com/. The TransCarotid Artery Revascularization (TCAR) Procedure is a clinically proven procedure combining surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke. The ENROUTE® Transcarotid Neuroprotection and Stent System are the first and only products specifically designed and indicated for TCAR in high surgical risk patients that need carotid intervention.

Similar jobs