Keywords
Process Engineering
Lean
Manufacturing
FDA
COO
technology
Medical Device
ISO 13485
China
Operations
catheter
CFDA
NPI
Transfer
scale up
GMP
CAPA
ERP
Audit
Consulting
Maintenance
Procurement
Clean room
Production plant
Management
Production
International
Supply Chain
Due Diligence
Strategy
Planning
continous improvement
Skills
- Working Knowledge of: UNI EN ISO 9001, ISO 13485, FDA 21 CFR PART 820V, MDDV, 510KV, GMP, GLP, GDP, GCP, Chinese CFDA, YY0033, ISO10993-7:2008, OSHA, ISO 8601, EN1041, EN11607, ISO 10012.
- Outstanding know how of Catheter and combo product manufacturing: PAD, PTA, PTCA, EPS, CPS, STENT, DEB.
- On the Field matured experience in Plastic Material Transformation technologies (compounding, micro-extrusion, injection and blow molding)
- Proven capabilities in building and kicking off production plants, speeding up NPI, rapidly scaling up production volumes, effectively transfer production lines, restructuring, business conversion revenue recovery
- Extensive track record of Lean Manufacturing, TPM and OEE projects for equipment and plants.
- Subject Matter Expert Process (SME) for Process Validation according to ISO 13485, FDA and CFDA.
- FDA and CFDA audits.
- Deep knowledge of Strategic Sourcing and Supplier management.
- Strong track records of Product lifecycle Cost Management initiatives
- Business acumen since product Industrialization, make or buy strategy and technology road map
Project history
2015 – Present
NT Industrial SAGL, Ticino, Switzerland
Founder, Owner
NT Industrial is focused on Integrated Operations strategy promotion, development and execution to support Med tech World Wide Manufacturers to rapidly and effectively take products from the design phase to the commercialization phase as well as add value at discrete stages of the production process.
The Consultancy operation range is within the medical device field and span from technical due-diligence to product portfolio assessment and rationalization, through Validation of complex class III finished medical devices, enhancing Mass or Niche Production, Product Line Transfer or Technology scouting and sourcing.
2015 – Present
Acotec Scientific Co. Ltd, Beijing, China
VP Operations
VP Operations in charge of: Production, Supply Chain, Engineering and Production Maintenance.
Working with International executive team, providing strategic decision to support company’s CEO enriching shareholder’s value.
Strong track record in structuring and leading Operations in China, from an early stage, pre-revenue or start up business, within pre and post product launch.
Playing a lead role in scaling Chinese Med Tech Company’s growth into successful business from zero production to thousand units/week of complex class II medical device (PTA and DCB catheters)
Provide direct leadership for multiple functions and facilitate local staff development of: manufacturing, engineering, maintenance, quality, supply chain, sourcing, procurement, planning, logistic
2010 – 2015
Medtronic Endovascular Therapies SpA, Italy
Head of Operations & Engineering
Head of Overall Operations functions across multiple Italian Facilities responsible of 500 blue collars and 50 white collars globally.
Member of Board of Directors for the Italian Sites, Member of CAPA Board , member of DCO Board, Member of Quarterly Management Review Board, Most Senior Representative for Operation within Italian BU, Member of PMS board, Technical Reviewer/Independent member for TOP TIER troubleshooting issue
Solid line reporting to the Italian Managing Director, dotted line reporting to Global VP Operations Medtronic Vascular based in Ireland.
2007 – 2010
Invatec SpA, Italy and Switzerland
Production Director
Medium High Tech International Company engaged in High Tech Medical Device field, 1.000 people, 170 million of revenue, 3 plants in Italy and 1 plant in Switzerland.
Main responsibility was to provide overall leadership and guidance among the 3 production facilities which consist of 350 workers.
Solid line reporting to the Company Owner and dotted line to the COO.
1998 – 2007
Fogazzi Srl, Italy
General Manager
Family owned OEM Company, center of excellence for high-tech polymers transformation processes such as advanced polymer characterization and precision extrusion, micro injection molding, assembling and packaging of Med. Device.
Full responsibility of the day to day business of the company which size was: 6 million € of revenue, 10 % EBITDA, 60 people. I delivered outstanding YOY revenue and profitability achieving company red target to triple the business within 3 years while dramatically increase operative margin
As a first in command, I reported directly to the Company’s owner.
NT Industrial SAGL, Ticino, Switzerland
Founder, Owner
NT Industrial is focused on Integrated Operations strategy promotion, development and execution to support Med tech World Wide Manufacturers to rapidly and effectively take products from the design phase to the commercialization phase as well as add value at discrete stages of the production process.
The Consultancy operation range is within the medical device field and span from technical due-diligence to product portfolio assessment and rationalization, through Validation of complex class III finished medical devices, enhancing Mass or Niche Production, Product Line Transfer or Technology scouting and sourcing.
2015 – Present
Acotec Scientific Co. Ltd, Beijing, China
VP Operations
VP Operations in charge of: Production, Supply Chain, Engineering and Production Maintenance.
Working with International executive team, providing strategic decision to support company’s CEO enriching shareholder’s value.
Strong track record in structuring and leading Operations in China, from an early stage, pre-revenue or start up business, within pre and post product launch.
Playing a lead role in scaling Chinese Med Tech Company’s growth into successful business from zero production to thousand units/week of complex class II medical device (PTA and DCB catheters)
Provide direct leadership for multiple functions and facilitate local staff development of: manufacturing, engineering, maintenance, quality, supply chain, sourcing, procurement, planning, logistic
2010 – 2015
Medtronic Endovascular Therapies SpA, Italy
Head of Operations & Engineering
Head of Overall Operations functions across multiple Italian Facilities responsible of 500 blue collars and 50 white collars globally.
Member of Board of Directors for the Italian Sites, Member of CAPA Board , member of DCO Board, Member of Quarterly Management Review Board, Most Senior Representative for Operation within Italian BU, Member of PMS board, Technical Reviewer/Independent member for TOP TIER troubleshooting issue
Solid line reporting to the Italian Managing Director, dotted line reporting to Global VP Operations Medtronic Vascular based in Ireland.
2007 – 2010
Invatec SpA, Italy and Switzerland
Production Director
Medium High Tech International Company engaged in High Tech Medical Device field, 1.000 people, 170 million of revenue, 3 plants in Italy and 1 plant in Switzerland.
Main responsibility was to provide overall leadership and guidance among the 3 production facilities which consist of 350 workers.
Solid line reporting to the Company Owner and dotted line to the COO.
1998 – 2007
Fogazzi Srl, Italy
General Manager
Family owned OEM Company, center of excellence for high-tech polymers transformation processes such as advanced polymer characterization and precision extrusion, micro injection molding, assembling and packaging of Med. Device.
Full responsibility of the day to day business of the company which size was: 6 million € of revenue, 10 % EBITDA, 60 people. I delivered outstanding YOY revenue and profitability achieving company red target to triple the business within 3 years while dramatically increase operative margin
As a first in command, I reported directly to the Company’s owner.
Time and spatial flexibility
- Comfortable with 80+ % travelling
- 3 years expat in China
- Worked for US, EU, ASIAN companies
Other
- Founder and Owner of a Swiss consultancy company focused on supporting Operations of high-tech Medical Manufacturers to vertically enhance Production, Supply Chain, Engineering, Quality, Safety and Infrastructure.
- In charge as VP Operations for an emerging Chinese Medical Device company, first in China with drug eluted angioplasty balloon catheter “DCB”.
- Seasoned professional contractor with proven expertise in promoting and executing a comprehensive Industrial Strategy to achieve company’s prodigious growth
- Dynamic change agent with consistent track record of brining manufacturers to the next level, extremely agile in managing heavy organizational restructuring or rapidly scaling up the business.
- Bottom-line contributor skilled in hitting P&L accountability, used to be accountable for an average operative budget of >10 Million $ in expenses and CAPEX.
- Outstanding Experience launching and leading multi-disciplinary and multi-site projects, building and piloting cross functional teams combining diverse company’s functions
- Creative innovator demonstrably able to provide product and process reengineering solutions that dramatically increase product margins while ensuring full compliance level, highest quality standard, safety and reliability.
- Proficient in setting a broad Supply Chain strategy, developing tactics and BI metrics that properly support company’s objectives.
- International experience in people management across different cultures and nationalities promoting culture of teamwork, cross contamination and sharing. Used to be responsible for hundreds of employee across multiple locations.
- Tremendous working knowledge of USA, EU and Chinese Medical Device Regulations and International Standards. Experienced in successfully facing On-site Inspections from notified body.