Senior Manager, R&D Engineering

Senior Manager, R&D Engineering

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

We are seeking a dynamic and experienced Senior Manager, R&D Engineering to lead an engineering team of approximately five teammates in the scale up and commercialization of the Coronary SELUTION Drug Eluting Balloon and subsequent SELUTION product iterations in Miami Lakes, Florida. The ideal candidate will have a strong background in Manufacturing Engineering, R&D design transfer into manufacturing, and functional management, with a focus on hiring and managing a team of development, process, and combination device engineers. This role requires exceptional leadership, strategic thinking, and the ability to work collaboratively across multiple departments and geographies (Irvine, CA).

Responsibilities :

• Design transfer into manufacturing facility in Miami Lakes, FL
• Hiring a team of approximately five Engineering teammates
• Establishes operational objectives, policies, procedures and work plans and delegates assignments to experienced level and professional teammates.
• Develops, modifies and executes company policies that affect immediate operations and may also have company-wide effect.
• Oversees execution of transfer and installation of testing equipment, coating equipment, and packaging equipment
• Oversees equipment qualification, test method validation, process validation, design validation testing, and bridging stability studies
• Accountable for developing and adhering to R&D and Operations transfer budgets.
• Works on issues where analysis of situations or data requires conceptual thinking and an in-depth knowledge of organizational objectives.
• Problems are not clearly defined and may lack strategic direction.
• Drives the strategic direction and success of product transfers
• Lead the engineering or technical leads with the purpose of completion of projects and the development of the pipeline of engineers and technical leads.
• Develop and manage department goals and drive completion of the goals.
• Collaborate with R&D, manufacturing, quality, and supply chain teams to ensure alignment and successful product launches.
• Identify and mitigate risks associated with new product introductions.
• Monitor and report on engineering or project technical progress and progress towards achieving Cordis goals.
• Drive continuous improvement initiatives to enhance product quality, reduce costs, and improve time-to-market.
• Ensure compliance with regulatory requirements and industry standards.

Qualifications :

Preferred Qualifications :

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.