Summary: Plan, organize and develop products, processes and experiments from idea inception through all stages of product development and technology transfers. All activities performed in adherence to applicable national/international regulations, guidelines, company policy, SOP’s and industry standards.
• Plan, organize and perform the necessary trials and experiments (bench-top, pilot plant, and factory
scale) as required to deliver the process and product development projects.
• Participate and contribute as a member of cross-functional teams as assigned. Interface on project
implementation teams by assisting with development through start-up and providing operational
training as required.
• Perform product development activities with a focus toward 510(k) clearance or PMA submission
requirements. Follow design control management and transfer process, Device history management,
Change control, Verification, Validation, Optimization testing and Stability studies, and translation of
• Develop SOPs, protocols, and reports. Document activities to ensure that newly developed products
meet the product specifications and all applicable requirements of the FDA, ISO, and CE mark.
• Function as a project team leader as assigned.
• Provide design control deliverables and develop performance measurements using statistical tools to
• Provide scientific and analytical support to perform evaluations in an effort to identify gaps in
performance data and recommend potential solutions.
• Skills in all MS Professional programs, including the ability to analyze complex data, create graphs using MS Excel, PowerPoint, and Visio, and use MS Project to create project plans and timelines. Direct project management experience is a strong plus.
• Technical writing
Education & Requirements:
• Bachelor’s degree (BSc) from four-year college or university required. 2 years related experience and training in Hemostasis or in IVD field. Working knowledge of coagulation systems and immunoassay methods (EIA / ELISA). Proven track record in full cycle development of IVD’s from Product Development to Manufacturing. Project Management, ability to lead cross-functional teams to
meet product development objectives.
• Valid Passport
• Travel up to 5%
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.
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