Senior Project Engineer
BioSpace · Tempe, AZ · 1 mo ago
EngineeringFull-time
About the role
The Project Engineer will contribute to the design, development, characterization, and lifecycle support of drug delivery devices and related combination products. They will work closely with cross-functional teams to advance robust, manufacturable, and patient-centered device solutions.
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 (e.g. 21 CFR 820 / Design Controls)
Requirements
- Bachelor's Degree in Mechanical or Biomedical Engineering and typically 10 years of experience, or Masters Degree or equivalent education and typically 8 years of experience.
- Experience in medical devices, combination products, or related product development environments
Qualifications
- Bachelor's Degree in Mechanical or Biomedical Engineering and typically 10 years of experience, or Masters Degree or equivalent education and typically 8 years of experience.
- Experience in medical devices, combination products, or related product development environments
Benefits
- Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k)
- Participation in short-term incentive programs
Pay
Salary range: $96,500 - $183,500 USD
Schedule
Full-time position