Note: The job is a remote job and is open to candidates in USA. Katalyst CRO is seeking an R&D Engineer to develop products, materials, processes, and equipment for moderately complex projects. The role supports product development, sustaining engineering, manufacturing, and process improvement through engineering studies, testing, documentation, CAD design, data analysis, and cross-functional collaboration.
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 preferred
- 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
Benefits
- Remote and onsite work model
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