Exciting medical diagnostics start-up seeks an R&D Program Manager to lead product development teams developing a new point of care diagnostic platform. The R&D Program Manager should have concept through regulatory development experience in medical diagnostics. All candidates should have strong experience with systems engineering.
This is not an executive leadership role, rather a “hands on” program manager role, managing all team members and elements of developing a medical diagnostic.
The company offers a generous compensation package including benefits, bonuses, profit sharing and opportunities for growth.
Requirements for the R&D Program Manager:
- Bachelor’s degree in engineering, mechanical engineering, bio-engineering or other relevant discipline. Advanced degree is preferred.
- 7+ years experience in medical diagnostics R&D
- Experience leading and managing diverse R&D teams, managing development, from feasibility, verification, validation, to regulatory submission of medical diagnostic products.
- Strong communications skills; oral, written and electronic
- Extremely self-motivated showing great professional initiative
- Strong working knowledge of medical device standards, ISO 13485, MDD and the regulatory submission process for medical diagnosis.
- Project management experience
- A track record of accomplishment in developing and mentoring R&D teams.
- Excellent analytical and organizational skills
- Ability to respond to changing priorities and to multi-task, in a dynamic environment
Responsibilities of the R&D Program Manager:
- Lead an R&D team of engineers, scientists, external partners and consultants responsible for research, product design and development.
- Lead teams in solving significant technical challenges; employ structured problem solving.
- Develop project schedules and budgets to support programs.
- Manage the product development process including the translation of user needs into product requirements, identification of all product design features or performance requirements for which a design path is not readily clear
- Develop and manage V&V requirements and risk management activities
- Ensure product development processes and activities meet appropriate safety and quality standards
- Manage budgetary objectives and make adjustments to project constraints based on financial analysis and strategy
- Foster a culture of excellence by providing ongoing leadership, mentoring, and coaching to all direct reports.
Occupational Category: 17-2031 Bioengineers and Biomedical Engineers