Sr. Product Development Engineer

Seeking a highly skilled Mechanical or Biomedical Engineer with 5+ years of product development experience to design and enhance spinal implants and instruments. Responsible for leading complete product development processes, including concept design, testing, and verification/validation. Must have proficiency in CAD software, knowledge of manufacturing processes, and familiarity with relevant standards and regulations. Excellent communication skills and ability to work in a fast-paced environment are essential. Experience in Spinal or Orthopaedic Implant design is preferred.

Responsibilities:

• Research, develop, and design spinal implants & instruments in compliance with FDA and ISO requirements.
• Lead complete product development process from concept to launch.
• Create designs using CAD (SolidWorks) for both subtractive and additive manufacturing methods.
• Write protocols, execute tests, and analyze data to verify designs meet specifications.
• Manage Change Order process for device-related changes and Quality Management System documents.
• Interface with customers, suppliers, and internal teams to ensure project milestones are met.
• Conduct stress analysis on designs using FEA and interpret results.
• Assist in the patent submission process.

Qualifications:

• BS in Mechanical Engineering or Biomedical Engineering.
• 5+ years of product development experience, preferably in Spinal or Orthopaedic Implant design.
• Proficiency in CAD software (SolidWorks preferred).
• Knowledge of manufacturing processes and materials for medical implants.
• Experience with GD&T, mechanical testing, and relevant standards and regulations.
• Strong communication skills and ability to manage multiple tasks in a fast-paced environment.

Physical Demands:

• Regularly required to sit and talk or hear. Occasionally required to stand, walk, use hands, and reach with hands and arms.
• May need to lift and/or move up to 25 pounds.

Work Environment:

• Typical office environment with moderate noise levels. Reasonable accommodations may be made for individuals with disabilities.