Fast Dolphin · 13 hours ago
Product Development Engineer
Lake County, IL
Contract
Onsite
Mid, Senior Level
$35/hr - $45/hr
1+ years expFast Dolphin is an international staffing company specializing in recruiting bilingual and multilingual IT experts. They are currently seeking a Product Development Engineer to work on an onsite project focused on medical devices and drug delivery systems, requiring a strong background in engineering and product development.
Enterprise Resource Planning (ERP)Information TechnologyStaffing Agency
Hiring Manager
Isabel Aleman
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
Required
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
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
Preferred
Product development experience and commercial scale manufacturing knowledge are preferred
Prior experience in technology transfer and process validation preferred
Prior knowledge of analytical methods and process development and characterization preferred
Hands-on experience working with contract manufacturing organizations (CMOs) requirements is a plus
Company
Fast Dolphin
Fast Dolphin provides staffing, outsourcing, IT technologies, consulting, ERP, Oracle, and SAP services.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Ramon Osuna
Senior Partner
Company data provided by crunchbase