Roman Haraja

Led cross-functional teams to successfully launch injection molded thermoplastic and silicone medical products for external customers, managing smooth transitions from design freeze to full-scale GMP manufacturing. Acted as primary liaison with customers, vendors, supply chain, and finance, providing project transparency, strategic guidance, and technical alignment. Quoted full NPI packages (tooling, validation, and production) to support business development. Created BOMs, process flows, protocols, reports, PFMEAs, packaging, training plans, and led IQ/OQ/PQs to ensure ISO 13485 and customer compliance. Guided manufacturability, material selection, and cost-efficiency improvements through customers' DFM reviews, mold design optimization, and secondary operations alignment. Fostered a high-trust team culture that encouraged collaboration, accountability, and continuous improvement.

Implement 20+ engineering change orders for administration sets and infusion pumps. Incorporate new plastic and metal materials, off-the-shelf components, and process improvements through industry research and customer feedback. Generate qualification, verification, and validation protocols and reports for contract and in-house testing facilities to ensure the product’s readiness for release. Validate product through performance, functional, and medical compliance testing both independently and in collaboration with external testing facilities. Collect relevant compliance data on 200+ components including ISO 10993, REACH, RoHS, and Conflict Minerals for North American and European distribution.

Designed and sourced injection molding cells for three new and five legacy shaving products in North America and Europe. Spearheaded a 3-month product line optimization at a Czech Republic sister plant, increasing output by 20%, saving over $500K, and preventing product line relocation amid rising global demand. Managed vendor selection, design reviews, and delivery of auxiliary equipment and tooling. Led debugging, qualification, validation, and production ramp-up of ten new molds at vendor and in-house facilities using scientific molding principles and root cause analysis. Conducted MoldFlow simulations on over 50 components, advising the product design team on manufacturability improvements to enhance mold performance and reduce defects. Drove continuous improvement initiatives, including digitalizing tooling revision workflows and integrating autonomous robots which led to 25% improvement in production efficiency.

Completed six IQ/OQ/PQ requirements for single, two shot, and insert-molded components. Developed process DOE(s), metrology inspection requirements, and work instructions for customers' products. Organized BOMs and control plans for medical, industrial, defense, automotive, and consumer goods.

Improved plastic part testing capability by adding 1000+ resins to the SolidWorks Plastics’ material database.  Established relationships with material suppliers to ensure accuracy of new and existing data Simulated customer’s components and provided design suggestions by utilizing SW Plastics add-on