Advanced Manufacturing Engineer II

About the position

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.

Responsibilities

• Design, development, and validation of new robust manufacturing processes for robotic Capital Equipment.
• 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.

Requirements

• 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.
• Proficient with 3D CAD, (Solidworks preferred), Excel, QMS and ERP systems.
• Experience developing and implementing manufacturing assembly processes.
• Capital Equipment 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.

Benefits

• Monthly social, catered lunches and company celebrations.