Advanced Manufacturing Engineer
Vicarious Surgical
Vicarious Surgical is seeking an Advanced Manufacturing Engineer to join our team in Bangalore, India. You will work with R&D and Manufacturing engineers to drive design for manufacturing and assembly activities during all phases of development.
Vicarious Surgical is a US based 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.
This is a terrific opportunity for an engineer to join our company at a very exciting time and be a key member of a team of mission-driven and kind individuals with diverse experiences to lead Vicarious into its next phase of market disruption.
This individual will be employed by a Professional Employer Organization (PEO), but doing work specifically for Vicarious Surgical.
Working hours of Monday through Friday (Office hours start at 3PM to ensure significant overlap with US hours)
Responsibilities:
- 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 that 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.
About You
- 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 - preferred.
- Working knowledge in statistical analysis, DOE’s, Gage R&R’s, capability studies and process validation essential.
- Experience developing and implementing manufacturing assembly processes. Medical device capital equipment and single use disposable product experience - preferred.
- Strong technical skill in SolidWorks, prototyping, tooling/fixture development and troubleshooting.
- Hands-on proficiency with machine shop tools and 3D printers.
- Solid understanding in materials, BOM structure, and best practices for complex device assembly.
- Demonstrated 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.
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.