Product Development Engineer
 Spectraforce Technologies | |
 United States, Illinois, North Chicago | |
 Apr 06, 2026 | |
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Description:
Title: Product Development Engineer Duration: 12 Months Location: North Chicago, IL Job Requirements * 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. Education: * BS degree as minimum requirements of 1-5 years * MS preferred 0-3 yrs * PhD acceptable in 0-3 yrs Ability to Commute: * North Chicago, IL 60064 (Preferred) Work Location: In person on site M-F | |