The Director, Connectivity and Cybersecurity, will provide strategic and technical leadership for Instrumentation platforms and Services within the R&D organization of the Critical Care Business Unit. The Director will be involved in the strategy, development and deployment of connected solutions that provide clinical, operational and economic benefit to Hospitals and other care providers. These solutions may include OEM technology integration into Edwards Instruments or the integration of Edwards’s technologies into OEM instruments; they may also include solutions that connect Edwards’s devices to other Hospital technologies such as EMR systems, HIS systems or other clinical devices.
In addition to driving connected solutions, the Director will manage the Cybersecurity strategies, processes and implementation requirements necessary to ensure that Edwards connected Instrument Systems are compliant with the appropriate regulatory requirements for Cybersecurity and provide the appropriate level of design and testing robustness to ensure that the Instrument systems remain safe and effective in a cyber threat environment that continues to evolve.
- Work with leadership teams, NPD Teams, global marketing and customer facing teams to develop and implement connected solution strategies, roadmaps, and product requirements.
- Manage the technical interface with external OEM Partners to drive Edwards technology integration projects.
- Support OEM Partners in generating system requirements and specifications.
- Provide engineering technical support for OEM Partners during integration projects.
- Work with NPD Teams to translate internal engineering specifications into OEM deployment documentation.
- Manage and support internal and external validation efforts for OEM partner integrations.
- Manage the post launch support and on-going technical relationships for OEM Partners.
- Manage and support the technical strategy and roadmap for Edwards EMR and HIS System Integration Solutions.
- Work with internal and external partners to define, implement, pilot and deploy integration solutions .
- Support Regional Marketing and Sales efforts for EMR/HIS integration efforts by acting as the point of contact for key questions and pre-sale consultations.
- Partner with internal cross-functional stakeholders (IT, Service, Marketing, R&D, QA, RA) for the design and implementation of infrastructure, processes and tools to support future connected solution functionality.
- Partner with NPD teams to define product interface requirements and technologies to ensure compatibility with future connected solutions roadmap.
- Lead Cybersecurity initiatives, including the development and deployment of processes to design cybersecurity features into instrumentation products and manage the on-going support of cybersecurity sustaining engineering tasks.
- Ensure regulatory filings and NPD projects incorporate cybersecurity considerations, design requirements and testing methodologies that comply with the guidance provided by US and international regulatory bodies.
- Keep up to date with cybersecurity trends, requirements and best practices that are applicable to the medical device industry.
- Supervisory Responsibilities: May manage several individual contributors
- A bachelor’s degree in Engineering, Computer Science or other relevant technical degree is required. Advanced degree is preferred.
- A minimum of 10 years of experience in product development, software solution development and/or IT solution development is required with at least 5 years in a leadership role. Experience medical device or healthcare solution development is required.
- Experience with Networked Solutions, Wireless standards, HIPAA standards, and cloud based solutions is required.
- Experience with EMR/HIS data integration solutions and/or OEM Device Integration solutions is required.
- Experience in the implementation and deployment of networked medical device solutions is highly preferred.
- Familiarity with cybersecurity requirements for medical devices, regulatory agency cybersecurity guidance documents and best practices in cybersecurityrisk management and new product development is highly preferred.
- Project Management experience is preferred. Ability to plan cross functional projects and the ability to control, execute, risk mitigate and communicate project status.
- Must be a highly motivated self-starter who is able to achieve results with minimal direction. Requires a high-energy individual who has excellent partnering, and negotiation skills. Must be proactive and creative in achieving goals and able to influence across the organization.
- Must be a driver for constructive process and system change.
- Effective communication, listening, and diagnostic skills are required to communicate with internal and external customers/stakeholders. Ability to work well independently and as a member of a team is essential.