Product Development Engineer II
Company: VIVEX BIOLOGICS INC
Location: Miami
Posted on: February 17, 2026
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Job Description:
Job Description Job Description Description: 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
Keywords: VIVEX BIOLOGICS INC, Pompano Beach , Product Development Engineer II, Engineering , Miami, Florida
