Mechanical Design Engineer
Job in
Denver, Denver County, Colorado, 80285, USA
Listed on 2026-04-28
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-04-28
Job specializations:
-
Engineering
Product Engineer, Mechanical Engineer, Manufacturing Engineer, Biomedical Engineer
Job Description & How to Apply Below
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 Solid Works.
- 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.
- bachelor's degree in mechanical engineering
- Minimum of 2+ years of mechanical design experience, preferably in medical devices within a regulated environment
- Proficiency in Solid Works
- Working knowledge of ISO and FDA design controls
- Experience supporting new product development from concept through testing and validation
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×