Senior Manufacturing Engineer

6 days ago

Fremont, California, United States THINK Surgical, Inc. Full time
Job Title: Senior Manufacturing Engineer

At THINK Surgical, Inc., we are seeking a highly skilled Senior Manufacturing Engineer to join our team. As a key member of our manufacturing team, you will be responsible for developing and implementing manufacturing processes for our robotic devices used in orthopedic surgeries.

Key Responsibilities:
  • Develop and implement manufacturing processes for robotic devices, ensuring high-quality products and efficient production.
  • Collaborate with cross-functional teams, including R&D and manufacturing operations, to ensure seamless product development and manufacturing.
  • Provide technical direction to vendors and suppliers to ensure compliance with manufacturing requirements.
  • Conduct process evaluations and implement improvements to reduce costs and increase efficiency.
  • Mentor and train junior engineers and manufacturing staff to ensure knowledge transfer and process consistency.
Requirements:
  • Bachelor's degree in Mechanical Engineering or equivalent field.
  • Minimum 5-7 years of experience in process development, preferably in medical devices.
  • Hands-on experience in manufacturing and assembly of complex electro-mechanical devices.
  • Strong knowledge of Design for Manufacturability (DFM) and Design for Assembly (DFA) principles.
  • Experience with CNC machining, fixture development, and equipment procurement.
  • Strong communication and problem-solving skills, with ability to work independently and collaboratively.
Preferred Qualifications:
  • Experience with PLCM software, such as Propel, and project management software, such as Confluence and Smart-sheet.
  • Knowledge of medical device regulations, such as 21CFR 820 and ISO 13485.
  • Experience with sterile medical instrumentation and disposables, in a regulatory environment.
Competencies:
  • Drives results and optimizes work processes.
  • Defends design and process choices, and holds stakeholders accountable.
  • Decisiveness in the face of constraints.
Physical Demands and Work Environment:
  • Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.
  • Physical activities include, but are not limited to, constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.
  • Occasionally work around moving mechanical parts.
  • Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.
  • Must be able to travel as business necessitates (up to 20%).

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