Mechanical Engineer
Core
Design, development, characterization, and lifecycle support of drug delivery devices and related combination products.
Role type
Mechanical Engineer (Medical Devices)
Builds
Injection drug delivery devices and combination products
Domain
Medical devices / Drug delivery
Deliverable
product features
Required skills
mechanical analysis, prototyping, testing, troubleshooting, root cause investigation, verification and validation, technical transfer, risk assessment, regulatory compliance (21 CFR 820)
Preferred skills
experience in medical devices, combination products, or related product development environments
Technologies
none stated
Responsibilities
Support design and development activities for injection drug delivery devices; Perform mechanical analysis, prototyping, testing, and troubleshooting of device components and assemblies; Evaluate device performance, identify failure modes, and support root cause investigations; Assist with verification, validation, and technical transfer activities; Collaborate with R&D, manufacturing, quality, regulatory, and suppliers to advance device programs; Generate and review technical documentation, test reports, specifications, and protocols; Support change control, risk assessments, and continuous improvement efforts; Contribute to device platform strategy, robustness, and manufacturability; Ensure all work is conducted in compliance with safety, quality, and applicable regulatory requirements.
Seniority
Mid-to-Senior level (8-10 years experience required)