Senior Project Engineer

Senior Project Engineer - Tissue-Based ProductsWe're looking for a Senior Project Engineer to drive the development of birth tissue, wound care, and pain management tissue-based products. This is an exciting opportunity for a skilled engineer to lead end-to-end product development, project management, and regulatory compliance efforts in a cutting-edge field.Key ResponsibilitiesLead product development projects from ideation through commercialization.Manage project timelines, budgets, and deliverables, while mentoring junior engineers.Develop and execute validation protocols in compliance with FDA and industry standards.Oversee risk management, regulatory compliance, and 510(k) submissions.Collaborate with Quality, Operations, and Regulatory teams to ensure successful product launches.Design and optimize manufacturing processes, supplier agreements, and risk management plans.Conduct scientific experiments, analyze data, and oversee equipment onboarding.Support regulatory submissions, compliance initiatives, and process improvements.What You Bring5-6 years of product development experience, including 4+ years of project management.Bachelor's or Master's in Biomedical, Tissue, or Mechanical Engineering (or related field).Proficiency in CAD, design controls, validation procedures, and regulatory standards (FDA, ISO, ASTM, etc.).Strong technical writing, problem-solving, and analytical skills.Experience with medical devices, allografts, and manufacturing processes (preferred).Ability to work independently and lead cross-functional teams through all phases of product development.This role is ideal for someone with deep product development experience who can independently manage projects, execute design control phases, and drive successful product launches in the medical device, biologics, or HCT/P space.

Created: 2025-02-19