DIRECTOR – PRODUCT DEVELOPMENT

Background

The Company has completed the engineering design of its initial clinical system and has demonstrated design feasibility through animal testing. As we transition from development stage to pilot manufacturing, preclinical testing and clinical introduction, we need to complete all product development to establish initial clinical efficacy, and then complete development of our final clinical system for long-term use. A seasoned and savvy leader is needed to make this happen.

Description

The Director – Product Development will participate as a member of the Management team and will help develop product development strategy. The Director will be primarily responsible to implement the organization’s product strategy. The immediate priority will be to complete development of an implantable LVAD system and bring it to market. Once the initial system is in hand, significant technology advancement and diversification opportunities will be the focus.

Reports to the CEO. Has direct responsibility for a team of 12-15 engineers and technicians. Has a high level of interaction with clinicians, key subcontractors, vendors, and development partners.

This Director position represents an outstanding career opportunity for the right individual: cutting-edge technical challenge; management challenge; high visibility in the medical device industry; participation in creating a new paradigm in implantable devices and heart failure treatment; potential for significant personal financial rewards.

Requirements

1. 12+ years of successful product development achievements – from concept through market introduction – with high tech, mechanical or electromechanical implantable medical devices, including successfully incorporating clinical needs into product features, and obtaining regulatory approval. Experience with complex, multi-component systems that integrate mechanical, electronics and software technology would be a strong plus.

2. 5+ years in senior management and leadership positions in a dynamic, effective, multi-disciplinary product development environment, including identifying, obtaining, organizing and motivating the right resources to get the job done.

3. Recruiting, hiring and successful supervision of highly skilled direct reports in areas of mechanical, materials, electronics, software engineering.

4. Exceptional project management and logistics skills. A history of setting realistic objectives in complex product development projects and managing all resources to successfully achieve the objectives.

5. Experience in developing a strong intellectual property portfolio.

6. Highly developed sense of urgency, decisiveness and accountability. The ability to establish a “get it done” culture and keep the product development organization focused on achieving essential priorities.

7. A hands-on, fast-paced style. An engineer who lives the job, grasps detail and is engaged and constructive in all aspects of the project while leading an exceptional team.

8. A pragmatic, logical decision-maker and balanced risk-taker. Able to make decisions without all information, able to find multiple solutions to issues, and make decisions based on risk/benefits. Demonstrated ability to integrate business imperatives into technical objectives and meet them.

9. BS degree in mechanical, electrical or biomedical engineering is essential. An advanced degree is highly desirable.