Profile Details

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USD 200 /hr

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Hire Dr. Toni Y.

Spain

USD 200 /hr

+15 years Associate Director on Medical Device, IVD assay developpment for Blood Type & Infectious diseases Screen (PCR)

Profile Summary

I'm an Instrument Engineer (electronic and SW) with an MBA (Digital transformation expert), with high skills in immunoassays development and integration, developing Medical devices for the Transfusion Business (DiaMed, BioRad). Owner of a few patents (see Linkedin profile), to allow multiplexed serology testing for Allergies, Blood Screening, Infectious diseases screening, Transplantation, and other business fields. Associate Director Project Manager of Molecular multiplexed assay, for Respiratory Panels (including SARS-COV-2) and Gastroenteritis panels, managing complex projects of more than 50Mi, with a cross-functional team across the world. Led some of the development of some of the most known instruments, used today on the Business transfusion market, Grifols, BioRad. - Leading own Innovative project of an Immunoassay panel, ELISA technology-based, for Blood SCreening at low costs: "www.ctcdiagnostics.ch" - Leading my own company to develop new instruments to improve customer productivity based on GEL Column technology, see the developed instrument here: "https://haemokinesis.com/products/system-s/" Expertise in leading medical device start-ups with success (3 companies), since my young age, prooving my entrepreneurial vision and strategy management (see Linkedin for detailed companies). 15+ years’ success in product development and launch, strategic account management, and business and marketing planning within the medical device and diagnostic industry. Accomplished professional with an entrepreneurial spirit and track record of innovation in instituting cost-effective healthcare technology solutions and shaping digital transformation roadmaps for medical institutions. Highly organized in leading teams on multimillion-dollar projects, aligning processes, and delivering business results within strict financial limitations. Demonstrated skills in identifying product requirements, recommending product improvements, and assessing and mitigating risks to achieve competitive advantage. Well-developed expertise in envisioning business and product strategies, conducting detailed market insight, and building relationships across all business sectors to drive productive change.

Subject Matter Expertise

• ★ Medical Device Development
• ★ Blood Banking & Transfusion Medicine
• ★ Product Development
• ☆ Molecular Engineering
• ☆ Immunoassay

Services

• Writing
• Research
• Consulting
• Product Development

Writing Copywriting

Research Market Research, Feasibility Study, Gray Literature Search

Consulting Digital Strategy Consulting, Scientific and Technical Consulting, Regulatory Consulting

Product Development Formulation, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Concept Development

Work Experience

Associate Director Project Management

QIAGEN GmbH

April 2020 - Present

Senior IVD & Medical Device Consultant

Self-employed

October 2016 - March 2020

Founder, owner and CEO

SYMBION MEDICAL SYSTEMS (SWITZERLAND)

May 2008 - July 2016

Instrument Department Manager (IVD Medical Device)

DIAMED (BIORAD Group)

August 1995 - April 2008

Education

Master of Business Administration - MBA & Business Digital Transformation

ThePower Business School

March 2020 - March 2022

Master of Business Information Systems

HEP-PH FR - University of Teacher Education Fribourg

September 2001 - June 2004

Engineer's degree, Electronic.

EPSIC - Lausanne (Switzerland)

August 1988 - June 1993

Certifications

• Expert Business Digital Transformation

  ThePower Business School

  https://verified.cv/en/verify/99116733674884?ref=email

  March 2022 - Present

• Expert Digital Business Administration

  ThePower Business School

  https://verified.cv/en/verify/36201619944718?ref=email

  July 2020 - Present