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Vivex Biologics · 2 months ago

Product Development Engineer II

Miami,FL,US

Full-time

Onsite

Mid Level

VIVEX Biologics is focused on researching and developing new production processes or products from bank human tissue. The Product Development Engineer II will be responsible for evaluating concepts, generating design documents, and coordinating with various departments to improve R&D efficiency.

BiotechnologyHealth CareTherapeutics

Responsibilities

Evaluate the feasibility of selected concepts to meet the clinical and customer needs

Generate design history documents in compliance with regulating bodies

Expert ability to design research approaches and design of experiments for assigned projects

Identify needs and goals for a new products and processes, including defining specifications and tolerances captured in user and engineering requirements

Coordinating with marketing and material suppliers to evaluate market needs and identify existing competition

Coordinating with finance to develop timelines and project plans and cost estimates of new products/processes developed, and to appraise management of performance against plan

Plan and organize engineering runs, including writing of validation protocols and testing instructions, and performing trials and analyzing data

Works specifically to develop new tissue products or processes and ensure proper technology transfer occurs, including identification of material and service suppliers, writing the necessary work instructions and SOPs, ensuring the final product/process meets regulatory compliance, and product safety

Can provide mentorship to junior scientists and engineers, including students and interns, to promote skills and growth

Other duties as assigned

Qualification

Product developmentDesign control processesAATB regulationsFDA regulationsCTBS certificationAnalytical skillsInvestigative skillsCommunication skillsProblem solving