Product Development Engineer II

6 days ago

Miami, Florida, United States VIVEX BIOLOGICS INC Full time

Job purpose

Under supervision of the Vice President of R&D, the Product Development Engineer II is responsible for researching and developing new production processes or products from bank human tissue, making modifications to existing manufacturing systems and processes, and to improve the overall efficiency of the R&D department.  

Duties and 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.

Requirements

Qualifications

  • BS, Advanced degree (Master's, PhD) a plus, in engineering. Relevant experience in product development preferred.
  • CTBS certified (or certified within two years of employment)
  • Thorough understanding of design control processes and requirements.
  • Strong knowledge of AATB and FDA regulations as they pertain to human tissue banks.
  • Excellent analytical, problem solving, and investigative skills.
  • Demonstrates excellent communication (both oral and written) skills.

Working conditions

Job requires working in office, laboratory, and manufacturing environments. There will be evening and weekend work.

Physical requirements

Job is one where the incumbent is required to stand for extended periods of time, lift heavy objects, and do repetitive tasks with few breaks while executing research plans.

Direct reports

N/A

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