Sr. Packaging Process Engineer
Core
Leads packaging process engineering projects from concept through implementation for orthopedic medical devices, driving innovation in sealing/forming equipment, vision systems, and labeling processes.
Role type
Senior IC packaging process engineer
Builds
Packaging processes and equipment for sterile and non-sterile medical devices
Domain
Medical device manufacturing / Packaging engineering
Required skills
Packaging process design, Heat-sealing process and equipment, Form-fill-seal automation, Modified atmosphere packaging, PLC/HMI programming, Vision systems, Regulatory standards (ISO 11607, FDA, GMP, ASTM, ISTA), Process validation, Change management
Preferred skills
Master's degree in Packaging/Mechanical/Industrial Engineering, Medical device industry experience, Labeling process expertise
Technologies
PLC, HMI, Vision systems, eDHR
Responsibilities
Lead packaging process engineering projects from concept to implementation, Pilot innovative technologies and equipment, Develop packaging processes including sealing/forming and vision systems, Support new product development and design transfer, Provide SME support for regulatory submissions, Mentor packaging engineering and production staff, Establish and maintain packaging validation processes, Provide technical support for equipment validations and process problem solving, Investigate packaging and labeling process concerns, Participate in NC/CAPA process and complaint investigations, Support equipment and supplier transfers
Seniority
Senior, hands-on IC