Therakos Healthcare Limited
Senior Engineer, Plastics and Mechanical Assembly
Therakos Healthcare Limited, Nashville, Tennessee, United States, 37247
Senior Engineer, Plastics and Mechanical Assembly
This role provides technical expertise and oversight for Contract Manufacturing Organizations (CMOs) supporting Therakos disposable sets and system components. The focus is on plastics, polymers, welding, adhesives, and chemical compatibility to ensure safe, compliant, and reliable manufacturing. The engineer serves as the technical liaison between Therakos and its CMOs, driving process validation, troubleshooting, and continuous improvement while ensuring adherence to regulatory standards.
Skills Strong background in plastics and polymer material science with practical experience in injection molding, extrusion, plastic welding (ultrasonic, laser, hot plate, RF), adhesives, and chemical compatibility testing. Excellent problem‑solving, documentation and validation in a regulated setting, and strong collaboration and communication skills.
Experience
Minimum 5 years in a manufacturing or technical role supporting manufacturing, focused on injection molding processes, and familiar with mold tool design criteria.
Successful completion of technical projects.
Preferred
Familiarity with chemical and ultrasonic welding/bonding for plastic components.
Previous experience working in a cGMP environment (medical devices or pharmaceutical).
Training in Lean Six Sigma methodology for continuous improvement.
Education Bachelor’s degree in Chemical Engineering, Plastics Engineering, Mechanical Engineering, or a related discipline is required; master’s degree preferred.
Training & Travel 25%–30% travel to locations in the US, Ireland, and the UK.
Job Responsibilities
Support design changes, sustaining engineering, lifecycle management, and risk management activities for the Cellex product line.
Lead issue resolution for materials, assembly, sterilization, and chemical compatibility challenges.
Partner with Quality to maintain compliance with ISO, FDA, and EU MDR requirements.
Collaborate with CMO to resolve nonconformances and drive continuous improvement.
Implement Lean Six Sigma tools to reduce variability and improve yield.
Document changes and validations in accordance with regulatory requirements.
Benefits
Life/AD&D protection.
Short‑ and Long‑Term Disability.
401(k) with company match.
Health Savings Account (HSA) and Flexible Spending Account (FSA) with company match.
Wellness Program.
Employee Assistance Program (EAP).
Generous Paid Time Off (PTO).
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Engineering and Information Technology
Industries Pharmaceutical Manufacturing
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Skills Strong background in plastics and polymer material science with practical experience in injection molding, extrusion, plastic welding (ultrasonic, laser, hot plate, RF), adhesives, and chemical compatibility testing. Excellent problem‑solving, documentation and validation in a regulated setting, and strong collaboration and communication skills.
Experience
Minimum 5 years in a manufacturing or technical role supporting manufacturing, focused on injection molding processes, and familiar with mold tool design criteria.
Successful completion of technical projects.
Preferred
Familiarity with chemical and ultrasonic welding/bonding for plastic components.
Previous experience working in a cGMP environment (medical devices or pharmaceutical).
Training in Lean Six Sigma methodology for continuous improvement.
Education Bachelor’s degree in Chemical Engineering, Plastics Engineering, Mechanical Engineering, or a related discipline is required; master’s degree preferred.
Training & Travel 25%–30% travel to locations in the US, Ireland, and the UK.
Job Responsibilities
Support design changes, sustaining engineering, lifecycle management, and risk management activities for the Cellex product line.
Lead issue resolution for materials, assembly, sterilization, and chemical compatibility challenges.
Partner with Quality to maintain compliance with ISO, FDA, and EU MDR requirements.
Collaborate with CMO to resolve nonconformances and drive continuous improvement.
Implement Lean Six Sigma tools to reduce variability and improve yield.
Document changes and validations in accordance with regulatory requirements.
Benefits
Life/AD&D protection.
Short‑ and Long‑Term Disability.
401(k) with company match.
Health Savings Account (HSA) and Flexible Spending Account (FSA) with company match.
Wellness Program.
Employee Assistance Program (EAP).
Generous Paid Time Off (PTO).
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Engineering and Information Technology
Industries Pharmaceutical Manufacturing
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