R&D Fellow, Systems Engineering, Interventional Platforms (San Diego, CA)

Working in research and development, the Systems Engineering Fellow will hold technical accountability to deliver the next generation interventional platform to market. This program technical leader will utilize knowledge in systems engineering, electrical medical system 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, including external engineering partners. 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 interventional platform, including seamless integration with the portfolio of connected devices; collaborating with cross-functional core team 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 internal and external engineering teammates, 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.

You're the right fit if:

• You have 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).
• You have the experience to build authority and accountability within a team, with strong expectation-setting, collaboration, and communication skills.
• You have demonstrated experience in systems engineering principles, including requirements engineering, tradeoff analysis, risk management, and configuration management; you have demonstrated the ability to formulate and solve problems; you complete work in a timely, accurate, and thorough manner.
• You have 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).
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together:

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office-based role.

Additional Information:

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
• Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to San Diego, CA.
• This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.