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 and Manufacturing engineers on new products to drive design for manufacturing and assembly 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’s novel approach to surgery uses a combination of proprietary, human-like surgical robots and virtual reality to transport surgeons inside the patient when performing minimally invasive surgery.

Responsibilities

  • Design, development, and validation of new robust manufacturing processes for robot disposable and capital equipment.
  • Contributor on product teams supporting Design for Manufacturing (DFM) elements and ensuring process capabilities meet targets for all design specifications.
  • 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.
  • 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.
  • Support manufacturing team in maintaining compliance with medical device quality system requirements, including corrective/preventive action closure and disposition of non-conforming materials.
  • Provide training or assist in training of production staff for assembly, testing, and the use of new equipment, methods, and procedures.
  • Work closely with suppliers to ensure purchased components and assemblies meet requirements and support production volumes.

About You

  • BS degree in Electrical, Software or equivalent degree is required. With 3+ years of manufacturing engineering experience in a highly regulated industry
  • Strong hands-on technical skills in prototyping, troubleshooting and test fixture development.
  • Experience with electronics and software for test and troubleshooting of equipment.
  • 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

Nice To Have 

  • Experience with electrical wiring, interconnects, and EMI, EMC testing.
  • Working knowledge of IEC 60601
  • Experience implementing medical device capital equipment manufacturing assembly

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