Product Development Engineer

Location: North Chicago, IL • Contract (1+ year)

About the role

A growing organization is seeking a Product Development Engineer to support the development, testing, and commercialization of medical devices, drug-delivery systems, and combination products. This role combines hands-on laboratory testing, experimental design, data analysis, and technical documentation while partnering closely with cross-functional teams throughout the product development lifecycle.

Responsibilities

• Plan, design, and execute laboratory studies supporting new product development and product investigations.
• Design and conduct DOE studies to evaluate product functionality, manufacturability, reliability, accuracy, sensitivity, and selectivity.
• Perform hands-on testing, characterization, and evaluation of medical devices, drug-delivery systems, and related products.
• Support design verification, design validation, and risk-based testing activities.
• Develop test methods, protocols, and strategies for new product evaluations and product/process investigations.
• Analyze experimental data, identify trends, summarize findings, and prepare technical reports and presentations.
• Support product and process optimization, technology transfer, scale-up, and transition to commercial manufacturing.
• Troubleshoot product and manufacturing issues and participate in investigations related to deviations, failures, and process performance.
• Create and maintain technical documentation, including SOPs, test protocols, reports, batch records, and validation documentation.
• Partner cross-functionally with Quality, Regulatory, Manufacturing, Supply Chain, Marketing, laboratory teams, and external manufacturing partners.
• Ensure development and testing activities comply with applicable cGMP, FDA, ISO, design control, and internal quality requirements.

Requirements

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Materials Science & Engineering, Biotechnology, Pharmaceutical Engineering, or a related engineering discipline.
• 1–5 years of relevant experience in medical device, drug-delivery system, combination-product, or related product development.
• Hands-on laboratory experience supporting product development, testing, characterization, and/or manufacturing processes.
• Experience developing and executing DOE studies, functional testing, and reliability testing.
• Experience with experimental data analysis and technical reporting.
• Experience supporting design verification and/or design validation activities.
• Understanding of product development and commercial-scale manufacturing processes.
• Strong technical writing, documentation, data reporting, and presentation skills.
• Ability to work independently while collaborating effectively within cross-functional teams.

Skills

• Knowledge or experience with batteries utilized in medical devices or drug-delivery systems.
• Familiarity with design controls, human factors/usability, risk management, FDA requirements, and applicable ISO standards.
• Experience supporting technology transfer and process validation.
• Experience working with contract manufacturing organizations (CMOs).
• Experience using electronic laboratory notebooks (ELNs).
• Proficiency with Microsoft Word, Excel, and PowerPoint.

Benefits

As a contract employee of Sterling, you are eligible to receive a full employee benefits package that includes:

• Paid time off and paid holidays.
• Three medical plans to choose from, plus dental and vision plans.
• 401(k) retirement plan.
• Employee Stock Ownership (ESOP) plan.

Pay

$40/hour (target).