Nicolas Padilla

Associate Consultant

Buenos Aires, Buenos Aires Province, Argentina14 yrs 6 mos experience

Highly Stable

Key Highlights

Expert in product development for medical devices.
Proven track record in managing complex projects.
Strong leadership in quality management systems.

Stackforce AI infers this person is a Healthcare Product Development Specialist with a focus on Medical Devices.

Contact

Skills

Core Skills

Product Lifecycle ManagementManufacturing ProcessesBusiness AnalysisQuality Management SystemRegulatory AffairsProduct DesignProject ManagementQuality ManagementProduct DevelopmentProduction Improvement

Other Skills

3D CAD modeling3D Design3D Modeling3D Printing3DEXPERIENCEAnalytical SkillsBiomedical EngineeringComputer SimulationsDashboardsEngineering DrawingsEnglishEnoviaFinite Element AnalysisHealthHealthcare

About

I am a professional with proven experience in the Medical Devices industry, with a focus on surgical and orthopedic products. I work as a product development project leader, providing support throughout the product lifecycle management, from the initial idea conception phase to the operational phases of project execution, product design, process development, process outsourcing, and the technological solutions that support them. I have successfully developed several implantable products and advanced manufacturing processes, all in compliance with international standards. In the orthopedic sector, I am an expert in hand prosthetics for amputees, leading the manufacturing, assembly, and calibration processes of the devices. I have experience in business consulting, both in local and international market companies, offering advisory services in product development (PD, R&D), quality and regulatory affairs (QARA), outsourced process management (Outsourcing), and business strategy and analysis (BI, BA). I have also held team leadership roles as Quality Management Manager (QMS) and as Technical Manager for O&P.

Experience

Freelance consultant, development & business planning

4 roles

Technical Consultant

Jun 2025 – Present · 9 mos · Buenos Aires Province, Argentina · Hybrid

ORTHOTICS & PROSTHETICS (O&P) Technical Consultant
Expert in upper limb prosthesis.
Management of manufacturing processes, suppliers and outsourcing.
Device installation and calibration (Bionics, Myoelectric and Mechanic devices)
Specialized technical service.
Key Clients:
BIOPARX (bioparx.com)
BM Medicine (bmmedicine.com.ar)

OutsourcingProduct Lifecycle ManagementManufacturing Processes3D PrintingTechnical Support

Quality Management Consultant

Feb 2020 – Mar 2022 · 2 yrs 1 mo · Buenos Aires, Argentina · Hybrid

Quality Management System Lead:
Review and creation of Work Instructions (WI) and Procedures (SOP).
Management of validations, testing laboratories, and calibration of critical instruments.
Monitoring of non-conformities and CAPAs.
Support on Regulatory Affairs
Internal Audit.
Support on ISO 13485 certification.
Key Accounts:
IDEAR SRL (idearsrl.com.ar)
KINETICAL SRL (kntmedical.com)
[Confidential] International Medical Devices manufacturing company

Product Lifecycle ManagementOrganizational SkillsAnalytical SkillsQuality Management SystemRegulatory Affairs

Product Design and Development Consultant (Medical Devices)

Sep 2019 – Mar 2022 · 2 yrs 6 mos · Buenos Aires, Argentina · Hybrid

Project Management for the Development of Implantable Medical Products (ISO 13485)
Surgical products Design & Development. Involved in all phases of product lifecycle, from the initial concept and design process, through to the production of the final device, including the instruments development (E2E projects)
Collaboration with medical, engineers, and technical teams to identify challenges and implement innovative solutions
Product design (3D CAD modeling). Generation of drawings and simulations.
Review and analysis of material suppliers. Strategies definition for manufacturing processes.
Product prototype design and evaluation through monitoring and testing of pilot production batches.
Validation Test analysis and management of testing laboratories (Mechanical, chemical, and biological compatibility tests). Writing of final reports.
Management of outsourced processes, collaborating with engineers and suppliers to support project activities.
Advice on Regulatory documentation process, Quality Management and Risk Management (GMP)
Key Accounts:
KEYMED Devices (keymeddevices.com)
[Confidential] Argentinian Medical devices manufacturer.

Product Lifecycle ManagementNew Product IdeasOrganizational SkillsUsabilityAnalytical SkillsProject Coordination+9

Manufacturing Process Consultant (Orthopedic Industry)

Dec 2016 – Mar 2022 · 5 yrs 3 mos · Buenos Aires, Argentina · Hybrid

ORTHOTICS & PROSTHETICS (O&P) Technical Consultant
Expert in upper limb prosthesis.
Management of manufacturing processes, suppliers and outsourcing.
Device installation and calibration (Bionics, Myoelectric and Mechanic devices)
Specialized technical service.
Key Clients:
BIOPARX (bioparx.com)
BM Medicine (bmmedicine.com.ar)

Product Lifecycle ManagementOrganizational SkillsAnalytical SkillsManufacturing ProcessesQuality Management

Accenture

Management Consulting Analyst | Industry X - Digital Engineering R&D

Mar 2022 – May 2025 · 3 yrs 2 mos · Buenos Aires y alrededores · Hybrid

I collaborated with companies to achieve their project goals, working closely with both local and global teams, leveraging and advising on cutting-edge digital technologies to deliver consistent value on every project. I supported projects as Business Analyst (BA) and Quality Engineer (QE).
As a BA, I have collaborated with a top-notch company with their platform migration and integration that involves QMS (eQMS Teamcenter), the Product Lifecycle Management (Enovia PLM), a new release of the client owned software (software as Medical Device), and Salesforce complaints management module. I have supported the Testing and Validation process and some QMS processes (SOPs and WI reviewing and writing). As additional value I have created a Dashboard with Looker studio for supporting the Post Market Surveillance process.
As a Quality Engineer, I revised and created technical drawings with GD&T requirements using SolidWorks. I managed design data with SolidWorks PDM, and 3D CAD models integration into Agile PLM (Oracle) to ensure product quality and data integrity. I also developed a dashboard with Looker Studio for visualizing business metrics and optimizing manufacturing processes.

Business AnalysisProduct Lifecycle ManagementOracle Agile PLMQMSQuality Control DocumentationTesting+11

Implantes fico srl

Senior Product Development Engineer

Dec 2016 – Nov 2018 · 1 yr 11 mos · Buenos Aires Province, Argentina · On-site

Design and development of medical implants products and its instruments according to ISO 13485 and GMP. Focused on joint replacement.
3D CAD modelling. Technical drawings
Finite Element Analysis. Test review and management.
Monitoring of the manufacturing process.
Risk management. Product Technical files
Support to QA&RA team
Product Validation on surgeries.
Technical Support to Physicians and instrumentation technicians.
Client and End User experience follow up
Achievements:
POLYGRAN® Double Mobility Hip Implant & Instruments - Dev. 08/2017 - 05/2018
PRESSPOLY® MultiHole & ClusterHole Trabecular Ti 3D printed Hip - Dev. 05/2018-10/2018 (functional prototype)
(more details in "Projects" section)

Product Lifecycle ManagementNew Product IdeasOrganizational SkillsUsabilityAnalytical SkillsProduct Development+1

Grupo ortopedia alemana

3 roles

Technical Product Manager

Promoted

Aug 2014 – Nov 2016 · 2 yrs 3 mos · On-site

Prosthetists team Lead (6 prosthetic technicians and 8 manufacturing staff)
Review and drafting of Work Instructions (WI) and Standard Operating Procedures (SOP).
Analysis and implementation of production process improvements (CAD-CAM).
Resource management. Advice on stock management.
Coordination of staff training.
Preparation of area reports and business indicators (KPIs)
Achievement: VORUM® CAD-CAM Equipment Installation for Orthopedic Industry
(find more details in "Projects"section)

Product Lifecycle ManagementOrganizational SkillsAnalytical SkillsQuality ManagementRegulatory Affairs

Product Specialist & Team Leader

Promoted

Jun 2012 – Jul 2014 · 2 yrs 1 mo · On-site

Team leader of prosthetic technicians and coordinator of manufacturing process of upper limb prosthesis. Specialized in Bionics Hands Prosthesis.
Advisor at stock management.
Technical training of new team members.
Technical support to Users and Physicians.
Product performance reports and documentation.
Product exhibitions at conferences

Organizational Skills

Field Engineer

Sep 2010 – Jul 2012 · 1 yr 10 mos · On-site

Upper limb prosthesis Technician
Technical and clinical user evaluation.
Prosthesis manufacturing and clinical application.
Technical support.
Advisor of new technologies for rehabilitation and orthopedic industry.
Setup, programming and technical support of Mobility equipment.
Expositor at conferences

Organizational Skills

Freelance consultant, development & business planning

Junior Project Engineer

Mar 2010 – Aug 2010 · 5 mos · Paraná, Entre Ríos - Argentina · Hybrid

Project: “Special adaptation of vehicle for wheelchair transport”
Management and Design of complete adaptation of a VAN vehicle to ensure safe transport for 3 passenger with wheelchair and 3 passengers with other mobility disorders.
Monitoring and control of project execution