R&D Engineer

Katalyst CRO; San Jose (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

Katalyst CRO is looking for an innovative R&D Engineer to support the research and development of new products in San Jose, California. The selected candidate will work through the entire product lifecycle, from concept to commercialization, ensuring compliance with quality and regulatory standards.

The ideal candidate will have a Bachelor's degree in Engineering and 3+ years of relevant experience, along with proficiency in CAD software. This role emphasizes collaboration with cross-functional teams to drive product design and continuous improvement.

Qualifications

• 3+ years of experience in Research & Development or Product Development.
• Experience with product design, prototype development, and testing.
• Strong understanding of engineering principles and manufacturing processes.

Responsibilities

• Design, develop, and improve new products and components.
• Collaborate with teams for product commercialization.
• Ensure compliance with industry standards and regulations.

Skills

CAD software proficiency

Analytical problem-solving

Design Verification & Validation knowledge

Cross-functional teamwork

Education

Bachelor's degree in Engineering

Tools

SolidWorks

AutoCAD

Minitab

Job description

Job Description

We are 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. This role involves product design, prototyping, testing, risk analysis, design verification and validation, and continuous product improvement throughout the development lifecycle.

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.

Requirements

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline.
• 38+ 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.

Preferred Qualifications

• 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.