Product Development Engineer

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Job Description

• Summary of Contractor 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.

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.

Requirements:

• Lab experiences of product development and manufacturing process at medical device, combination products, device-drug delivery.
• Conduct DOE and test the product…