Job Description:

Job: Sr. Medical Device EngineerLocation: Buffalo, NY (Direct Hire)Job Summary: Plans, designs, and develops production processes for single-use medical devices, ensuring compliance with customer specifications and company procedures.Job Duties:Leads customer projects, managing schedules and resources for successful project execution.Coordinates development activities internally and with customers to meet deadlines.Translates customer needs into engineering specifications and manufacturing processes.Ensures regulatory compliance with FDA, ISO, and other standards.Identifies materials, designs tooling, and optimizes production for volume, cost, and quality.Prepares engineering documents and oversees product testingvalidation.Designs and validates manufacturing tooling, equipment, and processes.Maintains engineering documents and stays updated on industry trends and technologies.Assists sales in estimating materials and labor for quotations.Mentors new Product Engineers.Demonstrates company values of honesty, integrity, and respect.Performs other duties as assigned.SkillsTechnical Skills:Strong communication and teamwork skills.Proficiency in Microsoft Office, Solidworks, and related software.Experience with Lean Manufacturing6 Sigma methodologies.Knowledge of injection molding, ultrasonic welding, or radio frequency welding.Knowledge:Familiarity with regulatory environments (FDA, FAA, ISO 13485).Preferred knowledge of medical device manufacturing and world-class manufacturing.Experience:4+ years of related experience.Experience in regulated environments.Familiarity with production line layout and process validations.Education:Bachelor's degree in Mechanical, Plastics, Biomechanics, or Biomedical Engineering.