Senior R&D Engineer: Test Methods & SolidWorks Tooling

Katalyst CRO; Boulder (CO); On-site; USD 105,000 - 145,000; Full time

Job summary

Katalyst CRO is seeking a Senior R&D Engineer in Boulder, CO to perform test method development and validation, fixture and tooling design using SolidWorks, and updates to product drawings. The role includes creating traceable documentation such as spec maps and DFMEAs, with oversight of design, quality, manufacturing, and project activities.

The position is contract through September 2026, requiring collaboration with internal teams and external suppliers to drive projects and ensure compliance

Qualifications

• Bachelor's Degree in Engineering required.
• 4+ years with design controls.
• 4+ years in FDA QSR/ISO 13485 environments.
• Experience with Test Method development.
• Experience with design verification/validation.

Responsibilities

• Ensure all Design Controls aspects.
• Develop and validate test methods; create risk documentation.
• Support manufacturing moves between vendors.
• Maintain product safety, quality, and compliance.

Skills

Design controls

Quality system understanding

Testing & method development

Root cause analysis

Troubleshooting

Documentation & traceability

Education

Bachelor's degree in Engineering

Tools

SolidWorks

Minitab

SAP

Windchill

Job description

Katalyst CRO is seeking a Senior R&D Engineer in Boulder, CO to perform test method development and validation, fixture and tooling design using SolidWorks, and updates to product drawings. The role includes creating traceable documentation such as spec maps and DFMEAs, with oversight of design, quality, manufacturing, and project activities.

The position is contract through September 2026, requiring collaboration with internal teams and external suppliers to drive projects and ensure compliance