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Overview

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.

Responsibilities

We are seeking a dynamic and experienced Senior Manager, Advanced Manufacturing Engineering, to lead an engineering team of approximately 5 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 Transfer, 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

+ Hiring a team of approximately 5 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.

+ This role will have direct reports up to Principal level engineers

Qualifications

Qualifications

+ Bachelor’s degree in engineering

+ 10+ years of experience in Leading Engineering Teams, with a focus on new product design transfer and commercialization

+ PMA Experience

+ Medical device product development and operations experience

+ Strong leadership and project or functional management skills

+ Excellent communication and interpersonal skills

+ Proven ability to manage complex projects and cross-functional teams

+ Strong analytical and problem-solving skills

Preferred Qualifications:

+ Experience in combination medical devices a plus

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

Preferred Qualifications

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one-s identity. All our teammate-s points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.

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**Job Locations** _US-FL-Miami Lakes_

**ID** _2025-12105_

**Category** _Research and Development (R&D)_

**Position Type** _Regular Full-Time_

CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact [email protected]