Medical Device R&D Engineer - Design, Prototyping & Testing

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

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.