Medical Device​/Combination Product Engineer

Engineer II

Pay Range: $35/hr to $40/hr

Location:

North Chicago, IL 60064

Work Type:
Onsite

Contract Duration: 1 year with possible extension

Job Summary:

The Engineer II will support the development, testing, characterization, and manufacturing scale up of medical devices, drug delivery systems, and combination products. The role will focus on laboratory studies, design of experiments, functional testing, product characterization, and technical data analysis. The engineer will support technology transfer, process development, optimization, validation, and commercial manufacturing activities. This position requires strong collaboration across engineering, laboratory, quality, regulatory, manufacturing, and supply chain teams.

The ideal candidate will bring hands on experience with electromechanical devices, drug device delivery systems, and regulated product development environments.

Key Responsibilities:

• Provide technical support for product development and laboratory scale up activities supporting commercial manufacturing of medical devices, drug delivery systems, and combination products.
• Design and execute experiments and DOE activities to evaluate product functionality, manufacturability, reliability, accuracy, sensitivity, and selectivity.
• Plan, execute, document, and analyze testing programs for design verification, design validation, product characterization, and risk assessment.
• Support laboratory execution, data generation, data analysis, results interpretation, technical summaries, and presentation materials for project meetings.
• Develop experimental protocols, functional testing methods, test plans, investigation strategies, and technical reports.
• Support technology transfer, process development, optimization, process validation, and scale up activities in collaboration with manufacturing partners.
• Work with contract manufacturing organizations to ensure technical alignment, operational readiness, and compliance with company standards.
• Troubleshoot manufacturing challenges and support investigations involving deviations, process failures, and product performance issues.
• Develop and review technical documentation including SOPs, batch records, validation protocols, test reports, and other regulated documentation.
• Apply applicable regulatory requirements, design controls, quality practices, and industry standards to product development and testing activities.
• Collaborate with cross functional teams including engineering, laboratory, quality, regulatory, manufacturing, marketing, and supply chain teams.

Required Qualifications:

• Bachelor of Science degree in biomedical engineering, mechanical engineering, chemical engineering, materials science, biotechnology, pharmaceutical engineering, or a related engineering discipline.
• One to five years of experience in medical device, drug device delivery system, combination product, or related product development environments.
• Hands on laboratory experience supporting product development, manufacturing process development, testing, and characterization.
• Experience with product and process design, development, design verification, and design validation.
• Experience with commercial scale manufacturing and understanding of manufacturing processes.
• Experience designing and executing experiments and analyzing technical data.
• Strong understanding of electromechanical device development, laboratory testing, drug device interactions, and system testing.
• Working knowledge of cGMP and applicable FDA, EMA, quality, and regulatory requirements.
• Strong technical writing, communication, collaboration, problem solving, and organizational skills.
• Ability to work independently, manage multiple priorities, and operate effectively in a fast paced environment.

Preferred Qualifications:

• Master of Science degree in a relevant engineering or pharmaceutical discipline.
• Experience with prefilled syringes, cartridges, autoinjectors, eye care delivery systems, eye droppers, aesthetic devices, or pump based drug delivery systems.
• Experience with batteries used in medical devices and drug delivery systems.
• Experience working with contract manufacturing organizations.
• Experience with technology transfer, process validation, analytical methods, process development, and process characterization.
• Knowledge of design history files, human factors studies, usability studies, and project management practices.

Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable