Job Description :
Min 3 year of exp
The Packaging Engineer will collaborate on process continuous improvement and product commercialization cross-functional project teams.
They are responsible for the design, development, and support of package systems and processes for sterile/non sterile medical devices including components, assemblies, and end items.
They are responsible for demonstrating high-level performance that delivers high-quality packaging on schedule, which meets customer, patient, and regulatory (USA & EU) needs.
Skills:
5+ years medical device packaging experience
Experience working with medical device products and in the healthcare industry
Development of packaging components, and assemblies for sterile (sterilized by Ethylene Oxide, Steam, Gamma methods)
Provide technical recommendations and implement changes in the packaging process and materials
Participate on cross-functional, cross-site project teams focusing on packaging, technology and process improvements
Experienced with Validation (IQ/OQ/PQ) as part of packaging processes
Technical documentation ( Protocl/report) ,Packaging SoPs,Procedures
Manage shelf life (accelerated and real-time) and biocompatibility testing for new packaging material combinations
Supplier identiifcation & qualification
Provide guidance/mentor junior Engineers
Experience working with ISO, ASTM, EU-MDR and standards related to packaging
Experience with Labelling
Working knowledge of project management methodologies
Demonstrated initiative; results oriented; willingness and ability to institute change
Process orientation and strong interest in continuous improvement
Ability to communicate effectively in multi-discipline environment, and cross cultures and level of organization
Proficient verbal and written communication skills; including experience in writing and presentation skills
Industry:
Medical
Education:
BE / BS