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SPECTRAFORCE · 16 hours ago

Product Development Engineer

North Chicago, IL

Contract

Onsite

Entry, Mid Level

1+ years exp

SPECTRAFOR is seeking a Product Development Engineer focused on medical devices and drug delivery systems. The role involves technical support for product development, cross-functional team engagement, and conducting experiments to ensure compliance with industry standards.

ConsultingCRMInformation TechnologyLegal

Growth Opportunities

H1B Sponsor Likely

Hiring Manager

Naina Rathi

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

Qualification

Medical device developmentProduct development experienceElectromechanical device knowledgeFDAISO standardsTechnical writing skillsProblem-solving skillsCommunication skillsCollaboration skills

Required

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 a must have

Ph.D., M.S., or B.S. in engineering training at chemical, mechanical, materials sci & eng, aerospace engineering., pharmaceutical related

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

Strong understanding of pharma or medical device product development and capability of problem solving to unique problems with solutions

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

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