R&D Engineer

Katalyst CRO; Carlsbad (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO in Carlsbad, CA, seeks an engineer to support product development, sustaining engineering, and process improvement for medical devices. You will collaborate with Manufacturing, Quality, Regulatory, Clinical, and Marketing teams and apply CAD tools (SolidWorks) to design fixtures and tooling.

Candidates should have a bachelor’s in mechanical engineering and 1–2 years in medical devices, with strong analytical and documentation skills.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• 1–2 years' experience in the Medical Device Industry.
• Experience in product development, sustaining engineering, or manufacturing projects.
• Strong analytical and problem-solving skills.
• Working knowledge of CAD software; SolidWorks preferred.
• Ability to interpret and create technical drawings and engineering documentation.
• Experience with Design Control, Risk Management, and Engineering Change processes preferred.
• Proficiency in Microsoft Office applications (Excel, Word, PowerPoint).

Responsibilities

• Contribute as a core team member on development, sustaining engineering, and process improvement projects.
• Support product design activities, including concept development, design modifications, prototyping, and documentation.
• Plan and execute engineering studies, experiments, and testing activities.
• Create and maintain engineering documentation, including specifications, reports, drawings, and design records.
• Utilize CAD software (SolidWorks) to support design activities for product, fixture, tooling, and test equipment.
• Design, procure, and coordinate fabrication of tooling, fixtures, and test equipment.
• Investigate technical issues related to product design, materials, manufacturing processes, and performance.
• Collaborate with Manufacturing, Quality, Regulatory, Clinical, and Marketing teams to achieve project objectives.

Skills

Analytical thinking

Problem-solving

Team collaboration

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

CAD drafting

MS 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.

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.