Bijaya Nepal

About Bijaya Nepal

I thrive at the intersection of engineering precision and healthcare innovation, knowing that each test contributes to devices that improve patient outcomes. With strong expertise in test equipment setup, experimental design, and cross-functional collaboration, I bring a detail-oriented and problem-solving approach to every project.Passionate about advancing medical technology, I am committed to continuous improvement and robust testing practices that drive product quality and reliability. I enjoy connecting with professionals in medical devices, quality engineering, validation, and system development to share knowledge and contribute to innovation in the field.Key Specialities:3 plus year experience in mechanical design software (Solidworks, Creo & Siemen NX) 2 plus year of FEA experience with a major focus on stress/strain analysisAdvanced knowledge of CFD simualtion including OPENFOAM/ANSYSKnowledge of Injection Molding, CNC Machining, Sheet metals and Lean manufacturingElectrical & Mechanical System Testing – Hands-on experience in validation, functional testing, and troubleshooting complex systems.Regulatory Compliance & Standards – Strong knowledge of FDA, ISO, and cGMP requirements in medical device testing.Test Lab Operations – Skilled in test design, execution, and data-driven analysis to ensure reliability and safety.Cross-Functional Collaboration – Partnering with R&D, quality, and design teams to resolve technical challenges.Continuous Improvement – Driving efficiency, accuracy, and process enhancements in testing and validation workflows.

Experience

1. Test Lab Tech

   Stryker

   Jun 2025 — Present · Portage, MI, US

   Drove design verification and reliability testing strategies for next-generation medical devices, reducing overall test cycle time by 30% through improved setup efficiency and adherence to GLP and industry standards.•Led test protocol development, verification planning, and performance characterization for next-generation thermal devices, driving a 20% improvement in thermal performance and measurable increases in product durability and lifespan.•Performed validation and sterilization testing with 99% compliance accuracy, ensuring alignment with regulatory expectations and supporting seamless Design Verification (DV) and regulatory submission readiness.•Partnered with Design Engineering, Quality, and Test Operations to identify early-stage system vulnerabilities and influence design decisions — contributing to a 15% decrease in post-launch field failures and overall product reliability.•Designed and developed custom test fixtures and test systems from concept through implementation, ensuring proper equipment selection, calibration support, and configuration to meet evolving product testing requirements.•Contributed to Design History File (DHF) documentation, ensuring compliance with design control requirements under 21 CFR Part 820.•Developed working knowledge of clinical device use cases and customer requirements through cross-functional collaboration with Clinical Sciences and Marketing teams during design verification activities.

Education

• McNeese State University

  Mechanical Engineering , Bachelor of Science

• Lamar University

  Master's degree, Mechanical Engineering(Concentration in Advanced Solid Mechanics and Reliability Physics)