Director Research & Development
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
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
- Responsible for leadership of cross-functional staff members; manages direct report and through those individuals as subordinate group leaders to the broader team
* Work includes potential exposure to human blood borne pathogens or other potentially infectious materials.
* Work includes potential exposure to radiation sources such as fluoroscope in a catheter laboratory setting.
* Work includes potential exposure to chemicals