Mechanical Design Engineer

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

Job summary

Katalyst CRO in Denver is seeking a Mechanical Design Engineer to lead new product development for needle-free drug delivery devices. You will create 3D models and production drawings in SolidWorks, while maintaining DHF and ensuring ISO/FDA design controls throughout the process.

Qualified candidates have a bachelor's in mechanical engineering and 2+ years in medical device design, with proficiency in SolidWorks and experience in regulated environments.

Qualifications

• Bachelor's degree in mechanical engineering or equivalent.
• 2+ years of mechanical design experience, preferably in medical devices.
• Proficiency in SolidWorks and working knowledge of ISO and FDA design controls.

Responsibilities

• Lead new product development from proof-of-concept through design verification for a needle-free drug delivery application, following a stage-gate NPD process.
• Create, refine, and release 3D models and production drawings for disposable and syringe-based components using SolidWorks.
• Author and maintain Design History Files (DHF) and support audits, inspections, and regulatory compliance activities.
• Ensure adherence to ISO and FDA design control requirements throughout the development process.
• Optimize designs for manufacturability and scale-up in collaboration with contract manufacturers and key suppliers.
• Manage prototype builds, testing iterations, and design refinements through vendor engagement and validation activities.

Skills

NPD process

Mechanical design

Regulated environment

Vendor collaboration

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

Job description

• Lead new product development from proof-of-concept through design verification for a needle-free drug delivery application, following a stage-gate NPD process
• Create, refine, and release 3D models and production drawings for disposable and syringe-based components using SolidWorks
• Author and maintain Design History Files (DHF) and support audits, inspections, and regulatory compliance activities
• Ensure adherence to ISO and FDA design control requirements throughout the development process
• Optimize designs for manufacturability and scale-up in collaboration with contract manufacturers and key suppliers
• Manage prototype builds, testing iterations, and design refinements through vendor engagement and validation activities

Roles & Responsibilities

• Lead new product development from proof-of-concept through design verification for a needle-free drug delivery application, following a stage-gate NPD process
• Create, refine, and release 3D models and production drawings for disposable and syringe-based components using SolidWorks
• Author and maintain Design History Files (DHF) and support audits, inspections, and regulatory compliance activities
• Ensure adherence to ISO and FDA design control requirements throughout the development process
• Optimize designs for manufacturability and scale-up in collaboration with contract manufacturers and key suppliers
• Manage prototype builds, testing iterations, and design refinements through vendor engagement and validation activities

Education & Experience

• bachelor's degree in mechanical engineering
• Minimum of 2+ years of mechanical design experience, preferably in medical devices within a regulated environment
• Proficiency in SolidWorks
• Working knowledge of ISO and FDA design controls
• Experience supporting new product development from concept through testing and validation