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Senior Director, R&D Engineering

Title:  Senior Director, R&D Engineering

Company:  The company is a global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring.

Relationship: Reports to the Vice President, R&D.

Location: Southern California

Key Responsibilities: The Senior Director, R&D Engineering is responsible for directing all aspects of research and development for transcatheter pulmonic valve therapy, specifically valvular repair and replacement implants, delivery systems and ancillary products. This leader will be responsible for leading a team and overseeing e cross-functional partnerships across the organization. Additionally, this individual will provide input and influence executive leadership on the development and execution of strategy for their product portfolio, and will report directly to the Vice President, Research & Development THV.

The ideal candidate will have good related medical device business acumen with an understanding of the financial and market implications of new technology development. He or she will lead product design and be accountable for achieving generational improvements of these transcatheter treatments of structural pulmonic heart disease technologies. He/she should be passionate about helping patients and changing the world.

Other responsibilities include:

  • Workforce planning and acquisition, talent management, staff development and coaching, and leading a fast-moving R&D organization which is expected to innovate, design, improve and test sequential generations of the transcatheter pulmonic implants and delivery system technology.
  • Provide specific input to the IP process and strategy to ensure the Company’s IP position is unassailable.
  • Advise and monitor on competitive development efforts.
  • Develop, monitor and control R&D budgets and expenditures.
  • Active participant and member of the THV R&D Leadership Team.
  • Accountable for the overall leadership of the Transcatheter Pulmonic Valve Replacement Program and the full cycle product development process from technological concept to product introduction. Provides direct leadership of R&D functional area of responsibility and facilitates achievement of cross functional program deliverables in partnership with: Clinical Affairs, Regulatory Affairs, Quality, Operations, Marketing and Global Health Economics and Reimbursement.
  • Create and reinforce a work environment that fosters innovation, and leads the charge in defining and executing current and future pulmonic product portfolio efforts.
  • Execute a successful, disciplined new product development process that is based on the concept of continuous improvement, a learning philosophy, and decisions regarding best use of resources.
  • Demonstrates focus on staff development, ethics and motivation through appropriate assignment of opportunities and training activities as needed to support achievement of both professional development goals as well as business goals.

Qualifications: Qualified candidates must have the following:

  • A minimum of 15=20+ years of demonstrated success providing leadership in cardiac medical device organizations and a strong track record of and enthusiasm for bringing innovative products to market. Experience in companies with at least $30 million in revenue.
  • Well versed in patent and intellectual property issues and ability to coordinate, as appropriate, with the legal team.
  • Direct experience with the PMA process.
  • Strong related medical device business acumen with an understanding of the financial and market implications of new technology development.
  • At least ten years of direct prior experience either with cardiac catheters or stent-based products (e.g. AAA, neuro stents, peripheral stents, biliary stents, etc.) Experience with both would be a plus.
  • Strong technical knowledge and execution skills with a demonstrated ability to design, optimize and realize product concepts that are clinically useable and that are manufacturable.
  • Has successfully directly taken a product through different Modules of FDA approval and commercialization on at least two occasions with success.
  • Experience working with key opinion leaders in the field to identify market requirements and translate them into product features.
  • At least ten years of experience leading teams of at least five.
  • Experience managing budgets of at least $5 million.
  • Proven success building a shared vision; inspiring others to action; setting clear direction; establishing plans consistent with that direction.
  • Demonstrates high emotional intelligence and self-awareness. Possesses the ability to remain calm, professional and composed in high pressure situations with critical audiences.
  • Displays broad perspective and effective judgment, and demonstrates well-reasoned problem solving and decision-making.
  • Demonstrates a sense of urgency; understands the importance of outperforming and outpacing the competition in meeting customer and patient needs.
  • Focused on technological innovation; incorporates leading-edge thinking into business; proposes and implements revolutionary change.
  • Ability to work in a matrix organization and lead cross functional teams.
  • Strong communication skills both written and verbal with demonstrated ability to effectively collaborate, influence and negotiate.
  • Strong entrepreneurial spirit and high integrity.
  • Ability to travel approximately 25-30% both domestically as well as internationally.

Education
BS degree in Engineering is required; MS/MA/MBA is preferred.

Compensation
The selected candidate will receive an attractive compensation package, which will be commensurate with experience, and will include a base salary, annual bonus, equity, and comprehensive benefits.

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