R&D Engineer

Katalyst CRO; Carlsbad (CA); On-site; USD 65,000 - 95,000; Full time

Job summary

Katalyst CRO in Carlsbad, CA is seeking an engineer to support product development, sustaining engineering, and process improvement for medical devices. You will participate in design, prototyping, testing, and documentation to drive informed design decisions.

Collaborating with Manufacturing, Quality, Regulatory, and Marketing, you will help ensure compliant processes, maintain design records, and translate requirements into robust product outcomes.

Qualifications

• 1-2 years' experience in the Medical Device Industry.
• Experience supporting product development, sustaining engineering, or manufacturing projects preferred.
• Strong analytical and problem-solving skills.
• Working knowledge of CAD software (SolidWorks preferred).
• 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.
• Experience within a regulated industry, particularly medical devices, is advantageous.
• Familiarity with Design Control, Risk Management, and Engineering Change processes is preferred.
• Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.

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 PDP and TPD systems through delivery of high-quality engineering outputs.

Skills

Analytical skills

Problem-solving

Education

Bachelor's Degree in Mechanical Engineering

Bachelor's Degree in Biomedical Engineering

Bachelor's Degree in Product Design

Bachelor's Degree in Materials Engineering

Related engineering discipline

Tools

SolidWorks

Microsoft Office

Job description

Purpose

Develops products, materials, processes, and equipment for projects of moderate complexity. Under limited supervision, plans and executes engineering activities to support product development, sustaining engineering, manufacturing, and process improvement initiatives. Compiles, analyses, and reports operational, test, and research data to establish performance standards for new or modified products, processes, and materials.

• 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.
• 15. Demonstrate knowledge of Product Development Process (PDP) and Technology/Product Development (TPD) systems through delivery of high-quality engineering outputs.

Purpose

Develops products, materials, processes, and equipment for projects of moderate complexity. Under limited supervision, plans and executes engineering activities to support product development, sustaining engineering, manufacturing, and process improvement initiatives. Compiles, analyses, and reports operational, test, and research data to establish performance standards for new or modified products, processes, and materials.

Roles & 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.
• 15. Demonstrate knowledge of Product Development Process (PDP) and Technology/Product Development (TPD) systems through delivery of high-quality engineering outputs.

Education & Experience

• 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.
• Experience supporting product development, sustaining engineering, or manufacturing projects preferred.
• Strong analytical and problem-solving skills.
• Working knowledge of CAD software (SolidWorks preferred) is desirable.'
• 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.
• Experience within a regulated industry, particularly medical devices, is advantageous.
• Familiarity with Design Control, Risk Management, and Engineering Change processes is preferred.
• Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.