Vicarious Surgical is hiring a Senior 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 phases. The Senior Advanced Manufacturing Engineer 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.
- Design, development, and validation of new robust manufacturing processes.
- Major contributor in product teams supporting design for manufacturing elements and ensuring process capabilities meet targets for all design specifications.
- Provide product and process DFM (Design for Manufacturing) recommendations to product development core team to enhance manufacturability and reduce product cost.
- Design, construct and validate assembly, manufacturing, and test equipment.
- Provide requirements input to R&D to ensure product and equipment design meets quality, ergonomic, safety, and cost and throughput.
- Assess process capabilities, prioritize process improvements opportunities, and innovate and implement process improvements meet quality, ergonomic, safety, cycle/TAKT time and cost targets.
- Lead the development of PFMEA’s and the development and execution of MFG. test and validation plans.
- Perform process capability analysis, failure analysis for discrepant production components, assemblies, or field returns, and troubleshoot manufacturing line issues.
- Support manufacturing team in maintaining compliance with medical device quality system requirements, including corrective/preventive action closure, disposition of non-conforming materials.
- Provide training or assist in training of production staffs for assembly, testing, and the use of new released equipment, methods, and procedures.
- Work closely with suppliers to ensure purchased components and assemblies meet requirements and support production volumes.
- BS degree in Mechanical, Electrical, Biomedical, Materials Engineering or equivalent degree is required.
- 5-10+ years of manufacturing engineering experience in a highly regulated industry; medical device company experience is helpful, but not required.
- Working knowledge in statistical analysis, DOE’s, Gage R&R’s, capability studies and process validation essential.
- Strong technical skill in SolidWorks, prototyping, tooling/fixture development and troubleshooting. Hands-on proficiency with machine shop tools and 3D printers.
- Hands on experience designing and setting up disposable and capital equipment medical devices.
- Solid understanding in materials, BOM structure, and best practices for flexible or rigid instrument assembly.
- Experience with process validation planning/execution, IQ/OQ/PQ protocols, and reports.
- Solid experience transferring products from R&D to manufacturing.
- Excellent knowledge of 21 CFR part 820 and ISO 13485.
- Excellent project management skills.