I’m an experienced product design engineer with a focus in the development of medical and consumer products. I worked at design consultancies for over 16 years, focusing on all kinds of very challengi... Read more

I’m an experienced product design engineer with a focus in the development of medical and consumer products. I worked at design consultancies for over 16 years, focusing on all kinds of very challenging projects.. Although I could tell you I like making things that improve people’s lives (which is true), and I'm passionate about engineering... I feel that’s a bit cliche. I decided to transition to freelance engineering because I know product development is challenging and complicated. I wanted to both make it more accessible to more people trying to get a product off the ground, as well as support teams when they are really in need of some help. Check out my Website and Portfolio at catinella. com Product development is hard work. Timelines are always tight, teams are always taxed, budgets can be thin, there are many late nights, and it can be very challenging to get a product launched. I wanted to directly help folks by providing some of my time, so they can get back some of theirs. - I'm skilled in identifying user requirements, managing budgets and schedules, conceptual engineering and feasibility, prototyping, testing, risk analysis, tolerance analysis, verification and validation, regulatory compliance, and new product launch. - I've lead small 2-4 person teams to large multi-disciplinary 14-20+ person programs consisting of human factors specialists, industrial designers, mechanical, electrical, software, and quality engineers. - I've developed a broad range of products from consumer and electronics products, to medical devices, to automation and robotics, to industrial processing systems. - I've navigated challenging technical problems through a process of breaking the problem down, identifying risks, asking appropriate questions, and mitigating risks to acceptable levels for moving forward. Some of my primary skills include: Brainstorming/Ideation Concept Sketching Concept Synthesis Project Management Issue Identification Risk Identification FMEAs Hazards and Risks Assessments CAD Development Drawings Development Analysis/Simulations Technology Research IP Analysis Prototyping Test Planning Requirements Definition Component Selection System Conceptualization System Architecture Design Cost Assessments Component Selection Electronics Integration Early Supplier Involvement Prototype Tooling Qualification Testing Low Volume Builds High Volume Builds Tolerance Analysis Design Refinement Supplier Selection Design for Manufacture and Assembly Cost Reduction Verification Testing Design Controls Supply Chain Development Assembly line setup IQ/OQ/PQ Build Instructions Pilot Builds Validation Testing Change Management Quality systems Design Controls ISO 9001 / 13485 / 14971