Drug Delivery Product Development Engineers

The Fountain Groups; North Chicago (IL); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading medical device company in North Chicago is looking for a professional to provide technical support for product development and scale-up manufacturing of medical devices and drug delivery systems. The role involves engaging cross-functionally, executing laboratory tests, and contributing to design and validation processes. Ideal candidates will have a relevant degree, hands-on experience in biomedical design, and familiarity with regulatory requirements. This position offers an opportunity to significantly impact the advancement of medical technology.

Qualifications

• 1-5 years of experience in medical devices or related fields.
• Hands-on experience with lab studies related to biomedical design.
• Strong understanding of cGMP and regulatory requirements.

Responsibilities

• Provide technical support for product development and scaling up manufacturing.
• Engage cross-functionally for drug delivery system product projects.
• Support experimental lab execution and data collection.
• Interface with project teams to develop tests and evaluate systems.

Skills

Problem solving

Technical writing

Data analysis

Education

BS degree in relevant field

MS preferred

PhD acceptable in relevant fields

Job description

• BS degree as minimum requirements of 1-5 years, MS preferred 0-3 yrs, PhD acceptable in 0-3 yrs with a degree in the field of biomedical, mechanical, chemical, materials science and engineering, biotechnology and pharmaceutical related engineering fields.
• experiences in medical devices, drug delivery systems, scientific investigation, lab experimental, capability of problem solving in problems solving for solutions,
• Hand-on experience with lab study related to biomedical and mechanical design and development, drug product stability and chemical reactions in primary containers.
• Experience in multiple Combination Products with the focus on electro-mechanical pump devices and primary containers for drug delivery, Excellent technical writing skills, data summary, technical report, slide presentation are required
• Product development experience and commercial scale manufacturing knowledge are preferred.
• Experience in developing medical devices, device-drug delivery systems, and/or combination products. Broad experience in product and process design, development, design verification and design validation and patient usability applications.
• Product development experience and commercial scale manufacturing knowledge are a must have. Strong understanding of electromechanical device development and process techniques, including design, development, lab testing, and drug-device interaction and system testing.
• Familiarity with cGMP, regulatory requirements (FDA, EMA), and quality assurance practices in medical device, drug-device systems and combination products biomanufacturing.
• Hands-on experience working with contract manufacturing organizations (CMOs) requirements is a plus.

Job Description:

• Technical support of produce development and leadership at lab study scale up for commercial manufacturing of medical devices, drug device delivery systems, and combination products.

• Cross-function engagement and team matrix working experiences in portfolios of drug delivery system product development projects.

• Advances in scientific and engineering of medical device related experimental DOE design of experimental activities for the engagements with internal teams and external partners.

• Supports the experimental lab execution, data generation and collection, results summary and slide deck preparation and presentation at weekly meeting.

• Interface engagement of the project cross-function team and governance process and forward-looking evaluation of potential risk with timely problem solving.

• Supports in tech transfer, process development, optimization, and scale-up activities. Work closely with contract manufacturing organizations (CMOs) to ensure technical and operational alignment with company standards.

• Plans, designs, executes, documents, and analyzes a regimen of tests to evaluate, verify and/or validate a system.

• Provide knowledge in pharmaceutical manufacturing processes, particularly small molecules and biological drug related device delivery systems and combination products

• Interface with project and laboratory teams to develop DOE and functional tests, experimental protocols, and new target evaluations.

• Assesses risks and creates test plans around risk priorities; analyzes results, states conclusions, and assesses residual risks after tests are complete; in addition, assesses adequacy of support for conclusions by test results.