Sr R&D Engineer

Katalyst CRO; Boulder (CO); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a Sr R&D Engineer in Boulder, Colorado to oversee design quality and project activities. The role primarily involves developing and validating new test methods, ensuring compliance with FDA Quality System Regulations.

The ideal candidate will have a Bachelor's Degree in Engineering, with over 4 years of experience in design controls and knowledge of SolidWorks, as well as mechanical design experience. This position is a contract role expected to last until the end of September 2026.

Qualifications

• 4+ years working with design controls.
• 4+ years working within FDA Quality System Regulations and ISO 13485.
• Experience with assessing quality and compliance impact on products.
• Mechanical design experience is a plus.

Responsibilities

• Ensuring all Design Controls aspects.
• Developing and validating new test methods.
• Maintains product safety and quality compliance.
• Designing and developing new tools using SolidWorks.

Skills

Design controls

FDA Quality System Regulations

ISO 13485

Test Method development

SolidWorks

Troubleshooting

Root cause analysis

Minitab

Education

Bachelor's Degree in Engineering

Tools

SolidWorks

SAP

Windchill

Job description

Job Description

• Manager is looking for a Sr R&D Engineer that would perform test method dev and validation, fixture and tooling design using SolidWorks, updates to product drawings using SolidWorks, as well as creation of traceable documentation, such as spec maps and DFMEAs.
• This position is a contract role, expected to complete by the end of September 2026.
• Provides oversight of the design, quality, manufacturing, and project related activities.
• Coordinates with internal functions and external suppliers to identify and execute projects.
• Applies project management and problem solving skills to manage multiple activities concurrently.
• Develops products, materials, processes, or equipment for projects of moderate complexity.
• Under limited supervision/guidance, compiles, analyzes, and reports operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.

Responsibilities

• Ensuring all Design Controls aspects.
• Developing new requirements, sourcing new requirements, creating and validating new test methods, creating new risk documentation, and performing all applicable testing.
• Supporting manufacturing moves from one vendor to another.
• Maintains product safety, quality, and compliance of all products.
• Trained in all aspects of change management (DCA, SCIA, SCAR, and PLCP).
• Supports any applicable R&D projects planning and activities.
• Understands and complies with all the regulations governing the quality system.
• Supports additional activities required by the business.
• Designing and developing new tools and fixturing using Solidworks for use in test method development and validation.

Requirements

• Bachelor's Degree in Engineering.
• 4+ years working with design controls.
• 4+ years working within FDA Quality System Regulations and ISO 13485.
• Experience with assessing quality and compliance impact on products for design and process changes.
• Experience with design verification and validations activities.
• Experience with Test Method development.
• Experience in troubleshooting and root cause analysis.
• Working knowledge of Minitab and SolidWorks.
• Preferred Qualifications:
• Has led projects to drive product design changes or process changes preferred.
• Mechanical design experience.
• Has participated in new product development projects, related product transfer and scale-up activities preferred.
• SAP and Windchill experience is a plus.
• Human Factors / Usability experience is a plus.