Tony Laruffa
Innovator and Solutions Expert for Product and Manufacturing Development
- Role
- Principal Engineer - R d at Bausch + Lomb
- Location
- Irvine, CA, US
- LinkedIn followers
- 500 followers
About Tony Laruffa
Uniquely qualified, results-oriented Senior Engineering Professional with 30+ years of diverse engineering experience in the Medical Device and Pharmaceutical fields offering a portfolio of knowledge for business success. Expert in hands-on product development, process development, equipment integration, cross-functional program management, and individual contribution. Proven leader with exceptional communication skills, personal skills, and the ability to lead multi-disciplinary teams of resources and drive accountability. Broad knowledge base of products, manufacturing operations, quality systems, and regulations including cGMP, FDA, MDD, ISO, CE, and USP guidance.My background and experience has provided a broad range of knowledge starting with solid manufacturing experience all the way to product development in the medical device arena. This means I can accelerate specific business needs through innovative solutions for nearly any application.Specialties- Medical Device Testing to ISO Standards- Medical Device Labeling- Regulatory Filing- Green Belt Certified- Establishing Standardized Multi-Location Manufacturing Platforms- Bringing Products from Development to Market- Purified Water Systems Design and Control- Strong Mechanical Aptitude- Strong Interpersonal Skills
Experience
Principal Engineer - R d
Aug 2013 — Present
Primarily responsible for the oversight of product development, testing, and stability of IOLs and insertion devices to ensure compliance with internal design requirements and regulatory requirements. Recognized as a subject matter expert for input to regulatory submissions and the development of product labeling.
Education
Rochester Institute of Technology
BS, Manufacturing Engineering
1985 — 1992
Skills
- Six Sigma
- Design of Experiments
- Manufacturing
- Lean Manufacturing
- Cross-Functional Team Leadership
- Gmp
- Quality System
- V&V
- Fmea
- Iso 13485
- Dmaic
- Design Control
- Medical Devices
- Capa
- Iso
- Fda
- Spc
- Validation
- Design for Manufacturing
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