Senior Design Engineer

6 days ago

Fort Lauderdale, Florida, United States LEAD3R Full time

LEAD3R is seeking a Senior Design Engineer with a medical device background to lead complex design projects for medical devices. The ideal candidate will have a deep understanding of engineering principles, medical device regulations, and manufacturing processes.

Key Responsibilities

  • Design Leadership: Lead cross-functional design teams to develop innovative medical device concepts, ensuring alignment with product requirements, regulatory standards, and manufacturing capabilities.
  • Technical Expertise: Apply advanced engineering principles and methodologies to design and optimize medical device components and systems, considering factors such as biocompatibility, functionality, and reliability.
  • Regulatory Compliance: Ensure that all medical device designs comply with relevant regulatory standards, including FDA, ISO, and other applicable requirements.
  • Risk Management: Conduct risk assessments to identify and mitigate potential hazards associated with medical device designs, ensuring patient safety and product quality.
  • Manufacturing Collaboration: Work closely with manufacturing engineers to optimize designs for manufacturability, cost-effectiveness, and scalability.
  • Project Management: Manage design projects from concept to commercialization, including planning, scheduling, budgeting, and resource allocation.
  • Mentorship: Provide technical guidance and mentorship to junior engineers, fostering a culture of innovation and continuous learning.

Qualifications

  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field.
  • Minimum 8 years of experience in medical device design and development.
  • Strong understanding of engineering principles, including materials science, mechanics, and thermodynamics.
  • Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and engineering analysis tools (e.g., FEA, CFD).
  • Knowledge of medical device regulatory requirements (e.g., FDA 21 CFR, ISO 13485).
  • Experience with design control processes and documentation.
  • Excellent problem-solving, analytical, and communication skills.
  • Ability to work effectively in a fast-paced, collaborative environment.

Preferred Qualifications

  • Advanced degree in engineering or a related field.
  • Experience with specific medical device technologies (e.g., implants, diagnostics, therapeutic devices).
  • Certifications in engineering or quality management.

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