Cordis
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, R&D 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 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 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.
JOIN OUR TALENT COMMUNITY
Joining our Talent Community is a great way to receive company news and updates, as well notifications on career opportunities and events that interest you! Please tell us more about yourself so we can align you with future opportunities that match your background, skills and interests.
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 GlobalHR@Cordis.com
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, R&D 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 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 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.
JOIN OUR TALENT COMMUNITY
Joining our Talent Community is a great way to receive company news and updates, as well notifications on career opportunities and events that interest you! Please tell us more about yourself so we can align you with future opportunities that match your background, skills and interests.
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 GlobalHR@Cordis.com