Cordis
Senior Manufacturing Engineer
at
Cordis
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
Provide advanced technical leadership in the design, development, and optimization of manufacturing processes.
Support scalability, quality, and cost‑efficiency across production operations, ensuring full compliance with GMP and ISO 13485 standards.
Lead process validation and continuous improvement initiatives in collaboration with Quality, R&D, and Operations.
Key Responsibilities
Lead complex process development and optimization projects to improve product quality and manufacturing efficiency.
Oversee validation activities (IQ/OQ/PQ) for new and existing equipment and processes.
Partner with R&D to ensure seamless design transfer and manufacturability of new products.
Provide technical leadership in troubleshooting and root‑cause analysis of process or equipment issues.
Develop and maintain manufacturing documentation, including procedures, work instructions, and specifications.
Drive Lean and Six Sigma initiatives to reduce waste, variation, and cost.
Evaluate and implement new technologies, automation, and tooling to support production growth.
Support risk management activities, including PFMEA updates and control plan development.
Mentor and provide technical guidance to junior engineers and technicians.
Participate in CAPA investigations, audits, and inspection readiness activities.
Collaborate closely with Production, Quality, and Supply Chain to ensure operational alignment.
Required Qualifications
Bachelor’s degree in Mechanical, Manufacturing, Industrial, or Biomedical Engineering.
5+ years of experience in manufacturing engineering within a regulated industry.
Strong knowledge of GMP, ISO 13485, and validation principles.
Proven success leading process validation, improvement, and scaling initiatives.
Excellent communication, project management, and technical writing skills.
Preferred Qualifications
Master’s degree or advanced engineering certification.
Lean Six Sigma Green Belt or Black Belt.
Experience with automation, robotics, or high‑volume assembly systems.
Prior experience in medical device or drug‑device combination manufacturing.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work‑authorized visa.
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 includes race, gender identity, age, disability status, veteran status, sexual orientation, religion, and many other aspects of identity. All our teammates’ 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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at
Cordis
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
Provide advanced technical leadership in the design, development, and optimization of manufacturing processes.
Support scalability, quality, and cost‑efficiency across production operations, ensuring full compliance with GMP and ISO 13485 standards.
Lead process validation and continuous improvement initiatives in collaboration with Quality, R&D, and Operations.
Key Responsibilities
Lead complex process development and optimization projects to improve product quality and manufacturing efficiency.
Oversee validation activities (IQ/OQ/PQ) for new and existing equipment and processes.
Partner with R&D to ensure seamless design transfer and manufacturability of new products.
Provide technical leadership in troubleshooting and root‑cause analysis of process or equipment issues.
Develop and maintain manufacturing documentation, including procedures, work instructions, and specifications.
Drive Lean and Six Sigma initiatives to reduce waste, variation, and cost.
Evaluate and implement new technologies, automation, and tooling to support production growth.
Support risk management activities, including PFMEA updates and control plan development.
Mentor and provide technical guidance to junior engineers and technicians.
Participate in CAPA investigations, audits, and inspection readiness activities.
Collaborate closely with Production, Quality, and Supply Chain to ensure operational alignment.
Required Qualifications
Bachelor’s degree in Mechanical, Manufacturing, Industrial, or Biomedical Engineering.
5+ years of experience in manufacturing engineering within a regulated industry.
Strong knowledge of GMP, ISO 13485, and validation principles.
Proven success leading process validation, improvement, and scaling initiatives.
Excellent communication, project management, and technical writing skills.
Preferred Qualifications
Master’s degree or advanced engineering certification.
Lean Six Sigma Green Belt or Black Belt.
Experience with automation, robotics, or high‑volume assembly systems.
Prior experience in medical device or drug‑device combination manufacturing.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work‑authorized visa.
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 includes race, gender identity, age, disability status, veteran status, sexual orientation, religion, and many other aspects of identity. All our teammates’ 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.
#J-18808-Ljbffr