Product Development Engineer

Title - Product Development Engineer

Duration - 12 Months

Location - North Chicago, IL

Summary of an Engineer

Focus on Medical Devices, Drug Device Delivery Systems and Combination Products

* BS degree as minimum requirements of 1-5 years (MS preferred and PhD acceptable) in the field of biomedical, mechanical, chemical, materials science and engineering, biotechnology and pharmaceutical related engineering fields.

* 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 pharma or medical device product development and capability of problem solving to unique problems with 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 to the patient for disease therapies.

* Excellent technical writing skills, data summary, technical report, slide presentation are required

* FDA and ISO standards, design history file, project management professional (PMP) experience will be helpful.

* Prior experience and knowledge of pre-filled syringe and cartridge, auto injectors, eye care, or eye droppers, aesthetics, and pumps will be helpful.

* Lab experiences of product development and manufacturing process at medical device, combination products, device-drug delivery.

* Conduct DOE and test the product functionality, manufacturability, reliability with the characterization for accuracy, sensitivity, and selectivity.

* Establish methods for product investigations, including analysis of testing programs for adequacy and sequence, compliance with requirements, and preparation of reports.

* Data analysis, summary and slide deck preparation, presentation of design, develop, and test medical devices and combination products.

* Excellent written skills, outstanding communication and interpersonal skills, and ability to work independently and manage time effectively.

Job Responsibilities:

* 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.

* Understands regulations, apply guidance and standards on design verification and design validation to test activities and work products; prepares documentation for compliance with standard operating procedures

* Develop and review technical documentation, including standard operating procedures (SOPs), batch records, and validation protocols.

* Troubleshoot manufacturing challenges and support investigations into deviations or process failures.

* Collaborate cross-functionally with marketing, quality, regulatory, and supply chain teams to ensure seamless operations.

* Stay up to date with industry trends and best practices in pharmaceutical product development and lab, pilot and scale up manufacturing and commercial production.

Qualifications

* BS degree as minimum requirements of 1-5 years (MS preferred and PhD acceptable) in the field of biomedical, mechanical, chemical, materials science and engineering, biotechnology and pharmaceutical related engineering fields.

* 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.

* Excellent problem-solving skills and ability to work in a fast-paced environment.

* Strong communication and collaboration skills to effectively engage with internal and external stakeholders.

* Excellent problem-solving skills and ability to work in a fast-paced environment. Strong communication and collaboration skills to effectively engage with internal and external stakeholders.

* Prior experience in technology transfer and process validation preferred. Prior knowledge of analytical methods and process development and characterization preferred.

* Broad knowledge in design controls, human factors studies, design verification/validation and usability studies.