Sam Priyaraj

Process Development and Sustainment @Sterling Industries

Vaughan, ON, CA

Support process design, development, verification, and validation activities for medical devices ensuring compliance to ISO 13485, FDA 21CFR 820, and applicable regulatory and customer requirements. • Contributes to manufacturability, operational efficiency and effective design transfer to manufacturing supporting successful product commercialization and ongoing internal quality system performance. • Support process development for new products including concept trials, prototyping, DOE, and scale-up activities. • Develop and optimize manufacturing processes for molding, assembly, and packaging. • Participate in DFM/DFA with Design Engineering and customers. • Define and maintain process requirements, specifications, and acceptance criteria. • Execute IQ/OQ/PQ validation activities including protocol authorship, execution and reporting. • Support tooling qualification (T0, T1, FAT/SAT). • Analyze process capability (Cp/Cpk), yield, and scrap. • Support root-cause investigations during pilot builds and early production builds. • Develop PFMEA, Control Plans, and process documentation. • Collaborate with automation partners, suppliers, and client engineering teams. • Contribute to continuous improvement to enhance efficiency. • Influences planning to prevent delays, production, and quality issues. • Participate or lead creation and maintenance of risk management files. • Critical Thinking Makes high-quality, risk-based design decisions that influence product safety, compliance, and manufacturing performance. • Mentor junior engineers and represent Engineering in technical discussions with clients and suppliers. • Excellent communication skills, able to influence cross-functional discussions with QA/RA, Operations, PMO, Tooling, and suppliers. • Skilled in developing and maintaining PFMEA and contributing to Risk Management Plans and ISO 14971 documentation.