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
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