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Packaging Engineer
Eingestellt von Michael Bailey Associates - Munich
Gesuchte Skills: Design, Engineering, Engineer
Projektbeschreibung
PACKAGING ENGINEER
Zurich Ariea -/Switzerland
Global Medical Device Company
ASAP - 6 Month Contract
JOB SUMMARY
The Packaging Engineer will be responsible for the designing, developing and validating a wide variety of package designs to support the development of class III medical device implants and associated devices that are of a complex nature.
He or she will work in a Matrix/cross functional product development environment and be primarily responsible for the project leader's role to bring new packaging materials through the process validation phases to commercialization.
Coordination of internal and external/contractor resources to implement solutions required to provide significant cost savings and solve engineering problems will be a primary focus.
Must have experience with materials, equipment and new technologies that drive packaging innovation resulting in competitive advantages across global platforms. Strong communication, teamwork and organizational skills are essential.
General Functions
Transfer and introduction of packaging items/solutions into commercial facilities/packaging centers, optimization, standardization and harmonization of existing packaging items
Development of business processes to be compliance according to 21 CFR 820 and ISO 13485 (Design Control, Protocols, Hazard Identification, reports etc.)
Packaging responsibility for Design Dossiers, Tech-Files, Design Verification and Shelf Life Testing according to ISO 11607-1
Packaging project leader for DOEs and sealing process validations according to ISO 11607-2
Responsible for the design, testing, documentation and implementation of sterile and non-sterile packaging systems for all company medical devices and instruments
Provides project management for support of new product introductions, line extensions and external development alliances.
SME for packaging related CAPAs, Complaints, Change Management, Internal and Supplier Audits, p-FMEAs and d-FMEAs, Post Market Surveillance
Responsible for compliance of Design History Files (DHFs) and required packaging material documentation, and required remediation of existing documentation
Good communication, teamwork and organizational skills are essential
IT knowledge eg MS Office is a must
This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions"
EDUCATION
B.S. in Packaging Engineering required M.S./MBA preferred, experience in packaging advantageous, or an equivalent combination of education and experience
A thorough understanding of applicable standards and requirements is a must.
Travel Requirements
5% - 10%Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Zurich Ariea -/Switzerland
Global Medical Device Company
ASAP - 6 Month Contract
JOB SUMMARY
The Packaging Engineer will be responsible for the designing, developing and validating a wide variety of package designs to support the development of class III medical device implants and associated devices that are of a complex nature.
He or she will work in a Matrix/cross functional product development environment and be primarily responsible for the project leader's role to bring new packaging materials through the process validation phases to commercialization.
Coordination of internal and external/contractor resources to implement solutions required to provide significant cost savings and solve engineering problems will be a primary focus.
Must have experience with materials, equipment and new technologies that drive packaging innovation resulting in competitive advantages across global platforms. Strong communication, teamwork and organizational skills are essential.
General Functions
Transfer and introduction of packaging items/solutions into commercial facilities/packaging centers, optimization, standardization and harmonization of existing packaging items
Development of business processes to be compliance according to 21 CFR 820 and ISO 13485 (Design Control, Protocols, Hazard Identification, reports etc.)
Packaging responsibility for Design Dossiers, Tech-Files, Design Verification and Shelf Life Testing according to ISO 11607-1
Packaging project leader for DOEs and sealing process validations according to ISO 11607-2
Responsible for the design, testing, documentation and implementation of sterile and non-sterile packaging systems for all company medical devices and instruments
Provides project management for support of new product introductions, line extensions and external development alliances.
SME for packaging related CAPAs, Complaints, Change Management, Internal and Supplier Audits, p-FMEAs and d-FMEAs, Post Market Surveillance
Responsible for compliance of Design History Files (DHFs) and required packaging material documentation, and required remediation of existing documentation
Good communication, teamwork and organizational skills are essential
IT knowledge eg MS Office is a must
This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions"
EDUCATION
B.S. in Packaging Engineering required M.S./MBA preferred, experience in packaging advantageous, or an equivalent combination of education and experience
A thorough understanding of applicable standards and requirements is a must.
Travel Requirements
5% - 10%Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Medien/Design, Ingenieurwesen/Technik