Mechanical Engineer

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 Engineering and typically 10 years of experience, Master’s Degree or equivalent education and typically 8 years of experience.
• Experience in medical devices, combination products, or related product development environments.

Qualifications

• Experience in mechanical engineering and device development
• Strong problem-solving skills and attention to detail
• Ability to work effectively in a team environment
• Knowledge of medical device regulations and standards

Skills

• Proficiency in CAD software
• Experience with mechanical testing and analysis
• Excellent communication and collaboration skills

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) plan
• Short-term incentive programs

Pay

$96,500 - $183,500 USD

Schedule

Full-time, On-site