Senior Mechanical Engineer

2 months ago


San Diego, United States X4 Life Sciences Full time

X4 Life Sciences are looking for a Senior Mechanical Engineer with over 5 years of experience in medical device development, product design, and mechanical engineering to join one of out Medical Device consultancy clients.


In This Role, You Will:


  • Lead engineering teams, advise clients, and manage the planning, design, and execution of projects, ensuring timely delivery of all deliverables.
  • Communicate effectively with clients regarding deliverables, design reviews, and deadlines.
  • Develop mechanical concepts for packaging strategies, mechanisms, and parts, balancing function, form, and budget requirements.
  • Perform concept development, prototyping, testing, and analysis in collaboration with industrial designers and human factors engineers.
  • Create 3D CAD models of parts and assemblies using SolidWorks or similar software, optimizing designs for manufacturability and assembly.
  • Plan and conduct formal verification testing, including developing test methods, validating them, analyzing data, and designing experiments.
  • Document design history file activities, including planning, system requirements, risk management, hazard analysis, design inputs and outputs, and test plans.
  • Stay updated on project progress, identifying and resolving any emerging issues with team members.
  • Occasionally travel to client sites, typically within a one-hour commute from our location.


Qualifications:


  • Bachelor's degree in mechanical engineering or a related field.
  • Experience in new product development, mechanical design, and engineering processes from concept to production.
  • Knowledge of FDA design controls (21CFR 820) and standards such as ISO 13485 and 14971.
  • Familiarity with sterilization, biocompatibility, sterile packaging, shelf-life, and validation testing.
  • Strong teamwork, interpersonal, and communication skills, with the ability to perform independently and collaboratively at a high level.
  • Ability to thrive in a fast-paced environment, manage projects and deadlines, and adapt to shifting priorities.


Apply to express your interest in the position or reach me directly at l.denham@x4lifesciences.com



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