R&D Engineer

Summary

Katalyst CRO is a company focused on developing innovative products and solutions. They are seeking an R&D Engineer to develop products, materials, and processes while supporting product development and manufacturing initiatives.

Responsibilities

• Contribute as a core team member on product development, sustaining engineering, and process improvement projects
• Support product design activities, including concept development, design modifications, prototyping, and engineering documentation
• Plan and execute engineering studies, experiments, and testing activities to support design and process decisions
• Create and maintain engineering documentation, including specifications, protocols, reports, drawings, and design records
• Utilize CAD software (e.g., SolidWorks) to support product, fixture, tooling, and test equipment design activities as required
• Design, procure, and coordinate fabrication of tooling, fixtures, and test equipment
• Investigate technical issues related to product design, materials, manufacturing processes, and product performance
• Analyze test results, identify trends, and formulate data-driven conclusions and recommendations
• Support engineering change activities and implementation of design or process improvements
• Collaborate with Manufacturing, Quality, Regulatory, Clinical, and Marketing teams to achieve project objectives
• Demonstrate knowledge of Product Development Process (PDP) and Technology/Product Development (TPD) systems through delivery of high-quality engineering outputs

Skills

• Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, Product Design, Materials Engineering, or a related engineering discipline
• 1-2 years' experience with in the Medical Device Industry
• Strong analytical and problem-solving skills
• Ability to interpret and create technical drawings and engineering documentation
• Experience analyzing and presenting technical data
• Understanding of engineering fundamentals, design principles, and manufacturing processes
• Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint
• Experience supporting product development, sustaining engineering, or manufacturing projects
• Working knowledge of CAD software (SolidWorks preferred) is desirable
• Experience within a regulated industry, particularly medical devices, is advantageous
• Familiarity with Design Control, Risk Management, and Engineering Change processes is preferred

Qualifications

Must Haves

• Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, Product Design, Materials Engineering, or a related engineering discipline
• 1-2 years' experience with in the Medical Device Industry
• Strong analytical and problem-solving skills
• Ability to interpret and create technical drawings and engineering documentation
• Experience analyzing and presenting technical data
• Understanding of engineering fundamentals, design principles, and manufacturing processes
• Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint

Nice to Haves

• Experience supporting product development, sustaining engineering, or manufacturing projects
• Working knowledge of CAD software (SolidWorks preferred) is desirable
• Experience within a regulated industry, particularly medical devices, is advantageous
• Familiarity with Design Control, Risk Management, and Engineering Change processes is preferred