Careers in MedTech

Job Title

Director, R&D

Company

Truvic

Description

SUMMARY: Plans, directs, and coordinates activities of designated R&D personnel, projects and project teams to ensure that company goals and objectives are met within prescribed time frame and funding parameters; transfer projects to manufacturing/contract manufacturer by performing the following duties personally or through leadership of the team.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:

  • Foster an environment of collaboration, growth, learning, and achieving at Truvic
  • Lead the R&D team by providing a direction that clearly supports corporate goals and objectives.
  • Collaborate with contract manufacturers and other suppliers and development partners.
  • Provide development opportunities for and manage the performance of R&D team.
  • Interface with Senior Management to review project goals and priorities.
  • Interface directly with members of Marketing, Clinical Affairs, Clinical Advisory Boards as appropriate, and industry Key Opinion Leaders to understand current and future product development requirements.
  • Lead clinical needs-based brainstorming activities leading to new design solutions.
  • Represent R&D in high level cross-functional discussions that potentially have an impact on the clinical, regulatory, and business needs of the organization.
  • Plan and formulate the overall development program timelines and budgets; organize resources according to project requirements.
  • Identify and assign resources to specific phases or aspects of project (e.g., product design and process development, pre-clinical studies, design and process characterization and qualification, finalization of specifications, strategic project/technical plans, etc.)
  • Monitor product complaints to understand issues with the devices. Utilize this knowledge to design improvements to the current device or for implementation to future designs.
  • Coordinate internal and external teams or individuals to rapidly prototype new ideas within the peripheral vascular thrombus management space, as required.
  • Review product design for compliance with engineering principles, company standards, clinical requirements, and related specifications.
  • Coordinate activities concerned with technical developments, scheduling, and resolving engineering design and test problems.
  • Direct integration of technical activities and related support activities (i.e., marketing, regulatory, quality, clinical, manufacturing).
  • Prepare and/or lead R&D engineering team through design control documentation and processes.
  • Develop project budgets and control expenditures within limitations of department and project budgets.
  • Attend professional meetings (e.g., Professional conferences, Symposia) to build network of contacts, advance technological knowledge and to ensure professional expertise is maintained.
  • Assist in maintaining the Truvic IP portfolio.
  • Other duties as assigned.

 

EDUCATION/EXPERIENCE:

  • Bachelor’s Degree in a related field. Advanced degree desirable. Vascular product experience a plus
  • 10+ years related experience in the medical device/pharmaceutical field, including 5+ years in medical device industry
  • A minimum of 5 years in a technical management role
  • Experience and involvement with MDRs, IDEs, PMAs and 510(k) filings preferred
  • Knowledge and interpretation of applicable regulations, guidelines and policy statements (QSR, MDD, and ISO) preferred
  • Excellent written and verbal communication skills; technical writing capabilities are a must
  • Proven ability to manage a team of professionals and prioritize multiple projects independently
  • Able to travel up to 25% of the time

 

SUPERVISION:

  • Responsible for leadership of cross-functional staff members; manages direct report and through those individuals as subordinate group leaders to the broader team
Published
November 9, 2021
Location
Campbell, California
Category
Medtech  
Job Type
Only registered members can apply for jobs.
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