Product Development Engineer

Title: Product Development Engineer
Location: North Chicago, IL
Hire Type: Contract 1+ yr
Compensation: $40/hr target
Benefits: As a contract employee of Sterling, you are eligible to receive a Full Employee Benefits Package that includes paid time off, paid holidays, 3 medical plans to choose from, dental & vision plans, 401(k), and an Employee Stock Ownership (ESOP) plan.
Must have Skill Set: 

• Medical Device / Combination Product Development: Hands-on experience developing, testing, and characterizing medical devices, drug-delivery systems, or combination products.

• DOE & Product Testing: Demonstrated experience designing and executing DOE studies, functional testing, and/or reliability testing.

• Design Verification & Validation: Experience supporting design verification, design validation, risk-based testing, and applicable design controls.

• Technical Data & Documentation: Strong ability to analyze experimental data and develop clear technical reports, protocols, and presentations.

Overview:
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 will combine hands-on laboratory testing, experimental design, data analysis, and technical documentation while partnering closely with cross-functional teams throughout the product development lifecycle. 

Job Duties: 

• 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.

Qualifications: 

• 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.
• 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.

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.