Isaac Vennik
I’m an engineer by profession and a curious builder by habit. I like tackling hard problems, learning new skills, staying active, living deliberately, and making time for the people and experiences that matter to me.
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Chronology
A concise view of my professional and educational history
Senior Staff - Business Process Owner, Design Controls
Design-controls process ownership, QMS integration, requirements and traceability, audit support, training, and enterprise-system implementation for Infusion.
Quality Assurance & Systems Engineering Lead
Requirements, risk, traceability, verification and validation strategy, design reviews, and DHF structure for a remote startup.
Senior Systems Engineer
Product remediation, platform compliance, feasibility strategy, architecture, requirements, risk, and verification and validation.
Director of Operations
Concurrent nights-and-weekends work building the processes, financial models, analytics, and digital systems used to launch and scale a physical therapy practice.
Senior Mechanical Engineer
Mechanical design, reliability, failure analysis, and verification strategy for Class III implantable infusion systems.
Process Engineer II
Measurement systems, test-method validation, process development, and manufacturing readiness for Watchman FLX.
Engineering Intern
Remote technical and market research for a synthetic bone-graft product, including failure analysis, competing-product assessment, and FDA-response support.
Master of Engineering in Biomedical Engineering
Graduate study included medical-device design, clinical needs finding, prototyping, and cross-functional product-development projects.
Mechanical Engineering Co-op
Test-method development, statistical analysis, supplier-quality work, and failure analysis for next-generation implantable infusion systems.
Bachelor of Science in Mechanical Engineering
Graduated magna cum laude.
Experience
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