The purpose of the Process Engineering Manager is to supervise a team of about 8-10 Process Engineers, in order to support Production Managers from a technical point of view.
This position exists to:
ensure technological and scientific knowledge used during products manufacturing and control (materials, products and processes);
collaborate with Production Managers and Quality in order to achieve planned manufacturing costs and targets;
collaborate with R&D and Equipment Development in order to guarantee new (or changes to) products and manufacturing processes development and qualification;
collaborate with Quality in order to manage CAPA and investigations;
ensure the compliance of manufacturing documentation.
ESSENTIAL JOB FUNCTIONS
Manage Process Engineers team in terms of workload and priorities, in order to ensure the control of all manufacturing processes;
Ensure technical support and proper technical information to transfer to Manufacturing Value Stream Groups;
Supervise Process validation and Design transfer: by use of internal procedure and methods and meeting international standards, support to documentation editing (i.e. Protocols definition, Risk Analysis preparation, Change Request evaluation, support to Validations and Reports finalization, Technical Specification editing), according to the internal QMS;
Ensure the management of CAPA and investigations;
Collaborate in the development of new processes.
KNOWLEDGE, SKILLS AND ABILITIES REQUIRED
The following bits of knowledge are necessary, listed in order of importance:
Strong technical knowledge in manufacturing processes in relation to quality aspects: deep knowledge of machining and assembly operations;
Expert in SPC, route causes analysis and problem solving techniques;
Deep knowledge of validation and verification techniques (Test Plan, Test Report, FMEA);
Good knowledge of Six Sigma principles (green belt certification is mandatory, black belt is a plus);
Good knowledge of Lean Manufacturing and continuous improvement principles;
Good knowledge of Medical device manufacturing regulations;
Good knowledge of common software (Microsoft Office), knowledge of Minitab/Statgraphic is a plus;
Good management of financial data and manufacturing KPI;
Basic knowledge of Electronic and Software technologies;
Basic chemical process knowledge;
Good knowledge of written and spoken English is mandatory;
The following soft skills are necessary:
People management (management of white collars is mandatory);
Fundamental the ability to relate to other middle managers inside organization;
Fundamental the ability to motivate and drive the team;
Focused to results achievement;
Able to foster teamwork and collaboration inside and outside the team;
Able to develop and engage collaborators.
Bachelor's degree in Engineering or in other technical/scientific subject (Chemistry, Physics, IT, ect.) or equivalent working experience of several years in production or engineering roles;
Green Belt Lean or Six Sigma certification is mandatory, the Black belt is a plus;
FMEA certification is a plus;
Training on people management is recommended.
Minimum of 8 years of experience in Manufacturing/Process engineering in a structured company, which follows a Quality System;
Experience in Medical device manufacturing or pharma is not mandatory, but it is considered a plus;
Minimum of 5 years of experience in team management.