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Advanced Manufacturing Engineer II

4 months ago

Waltham, United States Vicarious Surgical Full time

Vicarious Surgical is hiring an Advanced Manufacturing Engineer to join our team in Waltham, MA. We are looking for a forward-thinking, collaborative, self-starter to join a team of experienced engineers to help create our manufacturing foundation as we bring our first product to market. To thrive in this position, you will work with R&D engineers and Manufacturing on new products to drive design for manufacturing, assembly and test method development activities during all the phases.

The AME will ensure process capabilities are established early for new products and ensure design robustness for long term manufacturing. This position involves working to challenging schedules, requiring delivery of results in a dynamic environment.

Vicarious Surgical is a next generation robotics company developing a disruptive technology with the goal of increasing the efficiency of surgical procedure, improving patient outcomes and reducing healthcare costs.

Key Responsibilities

  • Design, development, and validation of new robust manufacturing processes for robotic single use disposable devices.
  • Contributor on product teams supporting Design for Manufacturing (DFM) elements and ensuring process capabilities meet targets for all design specifications.
  • Work closely with suppliers to ensure purchased components and assemblies meet requirements and support production volumes.
  • Contributor in the development of PFMEA's and the development and execution of manufacturing test and validation plans.
  • Design, construct and validate manufacturing assembly and test equipment.
  • Perform process characterization studies and implement process controls. Execute and document IQ, OQ, and PQ activities.
  • Assess manufacturing process capabilities, develop, prioritize and implement process improvement opportunities to meet quality, safety, cycle time and cost targets.
  • Troubleshoot manufacturing line issues and perform process failure analysis for discrepant production components, assemblies and field returns.
  • Provide training or assist in training of production staff for assembly, testing, and the use of new equipment, methods, and procedures.
  • Support manufacturing team in maintaining compliance with medical device quality system requirements, including corrective/preventive action closure and disposition of non-conforming materials.
  • Other duties as assigned.

About You

  • BS degree in Mechanical, Electrical, Biomedical, Materials Engineering or equivalent degree is required.
  • 2+ years of manufacturing engineering experience in a highly regulated industry; medical device experience - preferred.
  • Strong hands-on technical skills in prototyping, troubleshooting and test fixture development.
  • Experience developing and implementing manufacturing assembly processes.
  • Single use disposable product experience - preferred.
  • Solid understanding of materials, BOM structure, and best practices for equipment assembly.
  • Experience with process validation planning/execution, IQ/OQ/PQ protocols, and reports.
  • Working knowledge in statistical analysis, DOE's, Gage R&R's, capability studies and process validation.
  • Working knowledge of 21 CFR part 820, ISO 13485 and IEC 60601.

Together, we share a love for learning and we are passionate teachers. As a company, we set ambitious goals and individually, we share in that ambition. At the office, we enjoy each other's company during monthly social, catered lunches and company celebrations.

Please note that at Vicarious Surgical, we follow COVID-19 safety protocol, which may include compliance with vaccination, testing and masking requirements.