Medical Device Product Development Engineer

Sterling Engineering, Inc.; Chicago (IL); On-site; USD 47,000 - 63,000; Part time

Benefits offered by this job

Paid time off

Paid holidays

Medical plans (3)

Dental plan

Vision plan

401(k)

Employee Stock Ownership (ESOP)

Job summary

Sterling Engineering, Inc. is seeking a Product Development Engineer for contract work in North Chicago, IL. You will design, run, and interpret laboratory studies for medical devices, drug-delivery systems, and combination products.

The role combines hands-on testing, DOE, data analysis, and rigorous documentation while coordinating with Quality, Regulatory, and Manufacturing teams to ensure cGMP and ISO compliance.

Qualifications

• Bachelor’s degree in a related engineering discipline.
• 1–5 years in medical device or drug-delivery product development.
• Experience with DOE, testing, and design controls.
• Strong data analysis and technical reporting skills.
• Knowledge of FDA, ISO, and cGMP requirements.

Responsibilities

• Plan and execute lab studies for new product development.
• Design and conduct DOE studies to evaluate performance.
• Perform hands-on testing and characterization of devices.
• Support verification, validation, and risk-based testing.
• Develop test methods and protocols.
• Analyze data, summarize findings, and prepare reports.
• Assist with tech transfer and scale-up processes.
• Ensure compliance with quality and regulatory standards.

Skills

DOE studies

Lab testing

Data analysis

Technical reporting

Cross-functional collaboration

Education

Bachelor’s degree in Biomedical/Mechanical/Chemical/Materials Science & Engineering or related field

Tools

ELN software

Microsoft Word

Excel

PowerPoint

Job description

Sterling Engineering, Inc. is seeking a Product Development Engineer for contract work in North Chicago, IL. You will design, run, and interpret laboratory studies for medical devices, drug-delivery systems, and combination products.

The role combines hands-on testing, DOE, data analysis, and rigorous documentation while coordinating with Quality, Regulatory, and Manufacturing teams to ensure cGMP and ISO compliance.