高分子材料技术负责人--某500德资医疗公司亚太研发中心

Tasks*

1) Main tasks:

     Withminimal guidance and supervision of the Manager, coordinate all efforts formajor design and development projects from concept through release.

     Leadin the conceptualization, initiation, development and implementation of new andimproved packages and processes including: design generation, prototypedevelopment, engineering specifications, mold and machinery qualification,functionality and quality testing, and technology transfer. Will participate,and sometimes lead, multi-functional teams on these projects;

     Developand establish detailed engineering specifications for packages, processes,and/or equipment to ensure product function and cost effective manufacturing;including 3D CAD models, detailed drawings, specifications, inspections andtest methods, manufacturing procedures, sterilization procedures, and materialmanagement documents.

     ApplyDesign Control regulations in product development.

     Provideefficient and timely documentation and/or transfer of manufacturing andengineering technologies.

     Writetest protocols and provide test data to demonstrate feasibility of packagingand products.

     Writetest reports.

     Developcustom equipment to support small scale product assembly and testing.

     Interfaceregularly with vendors and consultants.

     Supportline manager and other project managers with Project Management techniques.Responsible for developing and executing project plans.

     Ensureeffective utilization of the Packaging Laboratory to coordinate and execute labevaluations, quality control procedures and test method development.  Support Divisional needs in identifyingquality defects and driving resolution

     Implementstandardization and simplification programs, and margin improvement projects

     Interfacewith cross functions to ensure project meets agreed upon goals. Continuouslyassess and communicate project results vs. goals and take corrective actionwhen required

     Collaboratewith Procurement to develop and help negotiate local, regional, or globalcontracts with suppliers.  Evaluate andcoordinate supplier’s activity related to on-going projects

     Understand,interpret and refine package testing procedures and standards to support theeffective design, validation, and implementation of new packages and packagingtechnology.  Provide meaningfulexplanations and forward actions to appropriate Division/Subsidiary personnel

     Identifyand provide rationale for funds needed to successfully deliver project goals

     Writeand present technical and business summaries for both technical and non-technicalpersonnel

     Buildcompetitive advantage by identifying, evaluating, and championing technicaladvancements, design trends and innovations in packaging.  Stay aware of supplier and competitor newdevelopments, and highlight to appropriate management as needed

     Develop,justify and execute capital projects related to packaging (i.e.molds/machinery)

     Identifynew platform/product opportunities that provide high end-user value

     Seekout and leverage technology to bring consumer value

     Developand utilize a broad network of technical resources to expedite projectcompletion

2) Secondarytasks:

     Offerguidance, support and mentorship to junior and senior level engineers.

3) Miscellaneoustasks:

     Otherduties as assigned.

Organization*

The functionincumbent reports to: Organizational unit:

CCS DevelopmentManager   

Important internalinterfaces:   Important externalinterfaces:

     Differentdepartments within the company

     GMQAP sites     Please list cooperation withimportant external companies, agencies, authorities etc.

     CFDA

     Materialssuppliers

RepresentationRules*

The functionincumbent is represented by:   Thefunction incumbent represents:

Technical Leader,CCS     Technical Leader, Sr. Engineer,CCS

Key PerformanceIndicators

Please listdistinguishing qualitative and quantitative features by means of whichperformance in the position can be measured.

     Takesownership of assigned projects and provides timely and quality completion ofproject deliverables, goals, and milestones.

     Protocolshave thorough study designs that meet project objectives and regulatoryrequirements.

     Designand development documentation (test records / reports / design history files /etc.) are high quality and in compliance with company policies.

     Interfaceswith cross functions to ensure project goals are achieved.

     Promotesinnovation and builds competitive advantage for products and technicalcapabilities of the Company.

     Servesas a mentor / leader for junior and senior level engineers and cross-functionalteam members.

 

Qualifications,experience, know-how and skills critical for success*

 

1) Requiredtraining and education:

     B.S.,M.S. or Ph.D. Degree in Packaging, Engineering or Material Science.

2) Requiredprofessional experience (in years):

     B.S.with at least 10 years of relevant experience, M.S. with at least 5 years, orPhD with at least 3 years of relevant experience.

     Experiencein pharmaceutical packaging design is desirable.

3) Importantpersonal qualities:

     Previousexperience in a multi-national company

     Experiencein the pharmaceutical and/or medical device industry, and familiarity with thedesign control process.

     Experiencecoordinating packaging development project with cross functions.

     Experiencein package testing and with package specifications

     Experiencewith Logistics and Operations and how they relate to packaging design

     Experiencewith sustainable packaging design methods and materials

4) Otherspecialized knowledge:

a) Technicalknowledge

     Understandingand experience with local and international testing standards.

     Anunderstanding of various packaging materials tooling design and schedulesdesirable

b) Languages

     Fluentin both spoken and written English and Chinese.

c) IT skills

     PackagingCAD design experience using both 2D and 3D applications

d) Productknowledge

     Familiarwith Dialysis products

5 ) Specialpersonal requirements:

     Candidatemust be able to work independently as well as under direction whilecontributing knowledge and experience to projects.

     Mustbe self-motivated, possess good interpersonal skills, and the ability to handlea wide variety of work assignments while meeting tight timelines.