Note: The job is a remote job and is open to candidates in USA. Katalyst CRO is seeking an innovative and detail-oriented R&D Engineer to support the research, design, development, and validation of new products and technologies. The ideal candidate will collaborate with cross-functional teams to transform concepts into commercially viable products while ensuring compliance with quality, regulatory, and customer requirements.

Responsibilities

• Design, develop, and improve new products, components, and manufacturing processes
• Support all phases of product development, from concept through commercialization
• Create engineering drawings, specifications, and technical documentation
• Develop prototypes and conduct feasibility studies to evaluate product performance
• Plan and execute design verification and validation (V&V) testing
• Perform root cause analysis and implement corrective actions for product and process issues
• Conduct Design Failure Mode and Effects Analysis (DFMEA), Process FMEA (PFMEA), and risk assessments
• Collaborate with Manufacturing, Quality, Regulatory, Supply Chain, and Operations teams to support design transfer and production readiness
• Support process validation activities, including IQ/OQ/PQ, as required
• Analyze test data and prepare engineering reports and technical presentations
• Ensure compliance with applicable industry standards, regulatory requirements, and company quality systems
• Drive continuous improvement initiatives to enhance product quality, reliability, and manufacturability
• Participate in design reviews, technical risk assessments, and engineering change activities

Skills

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline
• 3–8+ years of experience in Research & Development, Product Development, or Design Engineering
• Experience with product design, prototype development, testing, and engineering documentation
• Proficiency in CAD software such as SolidWorks, Creo, CATIA, AutoCAD, or Siemens NX
• Strong understanding of engineering principles, materials, and manufacturing processes
• Experience with Design Verification & Validation (V&V)
• Knowledge of Design Controls, Risk Management, and Design Reviews
• Strong analytical, problem-solving, and troubleshooting skills
• Excellent written and verbal communication skills
• Ability to work effectively in a cross-functional team environment
• Experience in Medical Devices, Biotechnology, Life Sciences, Aerospace, Automotive, Consumer Products, or Advanced Manufacturing
• Knowledge of ISO 13485, FDA 21 CFR Part 820/QMSR, ISO 14971, or ISO 9001 (depending on industry)
• Experience with statistical analysis tools such as Minitab or JMP
• Familiarity with DOE (Design of Experiments), GD&T, tolerance analysis, and DFM/DFA principles
• Experience supporting New Product Introduction (NPI) and design transfer activities

Company Overview

Company H1B Sponsorship