Senior/Staff Process Development Engineer

4 days ago

Burlingame, California, United States Triton Medical Robotics Full time

Triton Medical Robotics is a pioneering medical device company that is revolutionizing the field of endoluminal robotics. We are a lean, innovative, and ambitious venture capital funded Silicon Valley start-up that is committed to developing cutting-edge medical devices using our Dynamic Rigidization technology.

Job Summary:

The Staff/Principal Process Development Engineer will play a critical role in further developing our product and transferring it into a manufacturing setting. The successful candidate will possess a passion for medical device engineering and a record of successful process, tooling, and equipment design.

Key Responsibilities:

  • Collaborate with cross-functional teams to design and prototype novel manufacturing processes and equipment
  • Develop and maintain Manufacturing Process Instructions (MPIs), test methods, product drawings, and component specifications
  • Upgrade our manufacturing processes to ensure proper Design for Manufacturability (DFM) and maximum scalability of our medical devices
  • Initiate and implement programs to continuously improve quality, cost, and cycle time
  • Identify new potential vendors and suppliers, and maintain relationships with existing vendors and suppliers
  • Design and prototype novel manufacturing equipment and fixturing, and perform qualification activities as required
  • Support company goals and objectives, policies, and procedures that comply with FDA Quality System Regulations (QSR), ISO 13485, and any other applicable domestic regulations

Requirements:

  • Bachelor's or Master's degree in Mechanical or related engineering field
  • 5+ years of work experience as a process development or mechanical engineer
  • Demonstrated experience working with cross-functional teams
  • Generated and managed manufacturing documentation for a commercial medical device product (MPIs, LHRs, BOM, flowcharts, etc.)
  • Capable with CAD modeling, engineering drawing generation, DFM, tolerance analysis, and tooling design
  • Possess knowledge of process validation, GMP, and state-of-the-art manufacturing processes
  • Solid understanding of design controls
  • A driven outlook and a strong desire to succeed as an engineer, as a team, and as a company

Preferred Qualifications:

  • Experience with development of articulating endoscopes and catheters, particularly robotic
  • Experience with disposables/consumables
  • Experience in a start-up environment
  • Proficient with SolidWorks
  • Experience working with contract manufacturers

Triton Medical Robotics is an equal opportunity employer and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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