Ewald E. - Self-employed, Consultant, Auditor in Industry / Medical Technology, European Technical Sales Buntrock Industries

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Silandro, Italy

Experience

Jan 2025 - Present

8 months

Project manager / European Technical Sales / Consultant and Freelancer

Buntrock Industries Inc.

Build Legal Organization Europe:

Create requirements specification and issue project tender
Qualify potential legal and tax advisors
Implement the project

Build Logistics Distribution Organization Europe:

Create requirements specification and issue project tender
Qualify potential 3PL providers
Implement the project

Jan 2023 - Dec 2024

2 years

Herisau, Switzerland

Head Process Engineer MP

Huber+Suhner AG

Global responsibility for Process Engineering MP
Staff in Switzerland and Poland
Automotive IQ, OQ, PQ, PV&T, Training
Requirements specification / Functional specification, FAT, SIT/SAT, Commissioning
Supplier selection, qualification, management
Staff training
Process and production documentation
Industrialization
Regular supplier audits

Sep 2020 - Dec 2022

2 years 4 months

Herisau, Switzerland

Senior Process Engineer / Project Manager

Huber+Suhner AG

Process Engineering
Project management
Plastic injection molding
Automotive IQ, OQ, PQ, PVT, Training
Requirements specification / Functional specification, FAT, SIT/SAT, Commissioning
Supplier selection, qualification, management
Staff training
Process and production documentation
Industrialization
Regular supplier audits

Jan 2020 - Jun 2020

6 months

Schaffhausen, Switzerland

Medical Technology Design Transfer

Alcon Grieshaber

Project management in the redesign of a series of instruments in eye surgery
Device qualification
Process qualification
Staff training
Process and production documentation - MFP, DHR, PMVP, …
Work instructions, test planning …
Supplier qualification / Scope expansion

On behalf of Aristo AG, Zurich.

Apr 2019 - Dec 2019

9 months

Ludwigsstadt, Germany

Management consultancy

WOM (A Novanta Company)

Consulting the management in the area of production with the goal to ensure economic growth and expansion of sites through Lean management methods, implementation of production processes, implementation of change management methods and recommendations on personnel planning.

Supplier qualification
Qualification of parts for medical technology made of plastic (machined parts / injection molded parts cleanroom), aluminum, stainless steel and titanium
Consolidation of outsourced areas
Supplier audits to determine new sourcing options

On behalf of GULP, Munich.

Dec 2018 - Mar 2019

4 months

Ludwigsstadt, Germany

Project manager EMEA, Project manager, Interim Value Stream Manager (Medical Technology Tech Transfer)

NDS (A Novanta Company)

Relocation of manufacturing for medical devices from the USA to Germany
Documentation and validation of new processes
Review and, if necessary, requalification of devices and equipment for CE compliance
PVT builds
Supplier qualification
Certification according to ISO 13485:2016, FDA
Customer-specific qualification/validation according to ISO 13485, FDA (Karl Storz Tuttlingen, DePuy Synthes Cork, Stryker)
Process and product audits

On behalf of GULP, Munich.

Jul 2018 - Nov 2018

5 months

Ludwigsstadt, Germany

Project manager Germany, Project management (Medical Technology Tech Transfer)

WOM (A Novanta Company)

Preparation, planning and execution of relocation of "CNC manufacturing for medical parts" from Germany to England and China
Documentation and validation of the new processes
LAIR/FAIR of parts including process capability evidence
Initial sampling according to PPAP (Stryker)
Qualification/validation according to ISO 13485 (DePuy Synthes)
Planning and realignment of the supply chain
Supplier qualification, development of an ASL (Approved Supplier List)
Range of parts: Plastic (turned and milled parts), aluminum, brass, stainless steel, titanium
Product and process audits
Supplier audit at a packaging manufacturer

On behalf of GULP, Munich.

Apr 2018 - Apr 2018

1 month

United States

Assistant to project management, Project management

Buntrock Industries Inc.

Support for a partner company from the USA specializing in investment casting / precision casting.

Documentation of process optimizations and improvements
Range of parts: Titanium, aluminum, stainless steel

Oct 2017 - Apr 2018

7 months

Hanau, Germany

Project management (Process automation Medical Technology, Automotive)

Heraeus Germany

Process analysis / "Restart" of a project for new automated systems.

Supplier qualification VDA 6.3
Requirements specification/Functional specification
Machine installation
Machine qualification according to VDA 6.3 and IATF 16949
Process qualification according to ISO 13845
Requalification of the supplier, analysis of existing processes and transfer to new automated processes
Introduce and conduct centralized project management in Process Engineering
Range of parts: Platinum, platinum iridium, gold
Supplier audits at special machine builders and coordination of resulting action list

On behalf of FERCHAU, Frankfurt.

Jun 2017 - Sep 2017

4 months

Brescia, Italy

Project leadership and execution (Material flow optimization)

DUNGS / LaCibek

Supplier management
Ensuring supply
Reorganization of logistics planning and processes
Control of orders and coordination of capacities (Supply chain optimization) between the company in the Stuttgart area and the supplier including 5 subcontractors in Italy
Range of parts: Aluminum die casting
Supplier audits, also at subcontractors, initially weekly, later monthly monitoring
(3 months on site at the supplier)

On behalf of FERCHAU, Stuttgart.

Jan 2017 - Sep 2017

9 months

Italy

Project leadership and execution (Setup of a QMS according to ISO 9001:2015)

In a civil engineering company
Supplier management

Jan 2016 - Dec 2019

4 years

Israel

Technical Sales

Buntrock Industries Inc.

Area: Investment casting / precision casting.

Aug 2015 - Dec 2016

1 year 5 months

Italy

Project leadership and execution (Digitalization projects)

In civil engineering companies and SMEs.

Head of Production / Engineering / Development / Logistics

Swiss Holding

Responsibility for up to 9 plants worldwide. During this time built 4 plants from scratch and closed or relocated 4 plants (e.g. from Italy to Czech Republic – around 400 employees).

Summary

My skills - Production, Engineering, Project management, Supplier management
Many years of international leadership and management experience (executive and quality and environmental officer)
Process Engineering, Product development, Production and process technology
Metalworking industry, Plastic injection molding, Medical devices, Automotive
Design transfer / Industrialization - from design to compliant implementation, qualification, validation, verification, document management
Tech transfer / Relocation - from design to compliant implementation, qualification, validation, verification, document management
Lean management methods, value stream design and planning and control of value chains, Value Stream Management
Process optimization, Digitalization, Process design, IT facilitation of process representation in ERP projects
Project management experience leading interdisciplinary and cross-functional and cross-company teams, Multi-project management, Project Management Office, Project leadership, Management reviews
Project management experience in equipment procurement / Industrialization of new products in industrial and medical technology environments, project planning and tendering, requirements specification, functional specification, FAT, SIT/SAT, commissioning, DQ, IQ, OQ, PQ, PPAP
Supplier management, Supplier qualification, Supplier auditing