Director / Technical Program Leader - Intravascular Ultrasound (IVUS) Systems (San Diego, CA)

Philips•San Diego, CA

2d•$178,000 - $285,000•Onsite

About The Position

Director / Technical Program Leader - Intravascular Ultrasound (IVUS) Systems (San Diego, CA) Working in research and development you will hold technical accountability to deliver next generation integrated intravascular ultrasound pipeline to market. This program technical leader will utilize knowledge in systems engineering, electrical medical system design, consumable (catheter, guidewires, etc.) design, product development practices, and design controls, to drive timely and robust multidisciplinary product development effort(s) to market. The leader is expected to utilize their breath and depth of experiences to drive key technical and program decisions, anticipate and manage risk, and establish expectations for engineering design review rigor across a large R&D team. This individual will take ownership of project deliverables and facilitate the decision-making process with well-considered tradeoffs. Your role: You will lead the design, development, integration, and commercial launches of the next-generation intravascular ultrasound (IVUS) products onto the multi-modal interventional platform, collaborating with cross-functional teammates to ensure comprehensive program success. You will oversee the full system development lifecycle, including defining requirements, designing system architectures, and implementing solutions through product development, integration and V&V, ensuring compliance with medical device standards and global regulatory requirements. You will develop and execute engineering strategies and technical project management approaches across a multidisciplinary R&D team (hardware, embedded software, algorithms, single-use devices, etc.), that aligns with program goals and promotes collaboration with the cross-functional core team. You will engage with business leaders and voice-of-customer representatives to ensure that technical solutions align with customer needs and market demands; facilitating stakeholder discussions to prioritize features and reinforce business alignment. You will analyze complex technical challenges, present multiple solution paths, and help stakeholders make informed decisions; provide innovative and clear options to address technical hurdles.

Requirements

15+ years of R&D leadership developing and launching medical devices and a Bachelor’s or advanced degree in Engineering (Biomedical, Electrical, Mechanical, or related).
Experience to build authority and accountability within a team, with strong expectation-setting, collaboration, and communication skills.
Demonstrated experience in systems engineering principles, including requirements engineering, tradeoff analysis, risk management, configuration management
Demonstrated the ability to formulate and solve problems; you complete work in a timely, accurate, and thorough manner.
Experience working in the regulated medical device environment: demonstrating practical knowledge and experience with global regulatory requirements and industry standards (e.g., IEC 60601, IEC 62304, IEC 62366, UL, ANSI, ASTM, ISO, FDA).

Responsibilities

Lead the design, development, integration, and commercial launches of the next-generation intravascular ultrasound (IVUS) products onto the multi-modal interventional platform, collaborating with cross-functional teammates to ensure comprehensive program success.
Oversee the full system development lifecycle, including defining requirements, designing system architectures, and implementing solutions through product development, integration and V&V, ensuring compliance with medical device standards and global regulatory requirements.
Develop and execute engineering strategies and technical project management approaches across a multidisciplinary R&D team (hardware, embedded software, algorithms, single-use devices, etc.), that aligns with program goals and promotes collaboration with the cross-functional core team.
Engage with business leaders and voice-of-customer representatives to ensure that technical solutions align with customer needs and market demands; facilitating stakeholder discussions to prioritize features and reinforce business alignment.
Analyze complex technical challenges, present multiple solution paths, and help stakeholders make informed decisions; provide innovative and clear options to address technical hurdles.