This highly collaborative manufacturing engineering role supports and leads various aspects of the dV5 Manufacturing Line, primarily focusing on testing processes. It involves providing real-time technical support, resolving failures, and contributing to design for manufacturability. The position requires strong communication and presentation skills to partner effectively with engineering, production, and management teams.
Responsibilities
Demonstrate ownership of various manufacturing processes, including assembly and test
Provide real-time (onsite) technical support for issues as they arise
Resolve failures of varying complexity, which may be related to process, hardware, or software
Identify root cause and implement solutions to improve manufacturability
Present data and proposals at project team meetings or wider audience forums
Provide critical DFM (Design For Manufacturability) input to development teams for software processes and electrical-based sub-assemblies
Develop and utilize understanding of system error codes, P values, and UID test functions
Assist with execution of purges and other major quality control processes for production when product defects are identified
Own and execute Production Process Qualifications (PPQ) for the manufacturing line
Assist with major PPQ (full line or factory) validations
Participate in project teams for CAPAs, MCF (design changes), EDF (field issues), root cause analysis, DPU reduction, process improvements, and cost reduction
Establish good working relationships with close functions (Production, Quality Engineering, Design Engineering, Supplier Engineering, etc.)
Execute complex DMR/DHR, BOM, and traveler document changes with little oversight
Translate factory/production data into actions or recommendations for improvements, with understanding of: DPU, yield, CPk, and trend charts
Use statistical tools independently to drive data metric reporting and improvements
Participate in risk analysis project teams whose intentions are to identify compliance gaps that may affect yields and quality metrics
Understand implications of lifecycles and how they are used in product development
Occasionally informally mentor or supervise colleagues
Perform other duties as required
Requirements
BS degree in Computer Science/Engineering, Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or other similar field
3+ years experience in a manufacturing or design-related role
Basic engineering principles and analysis techniques
Solid understanding of computer architecture
Solid understanding of computer networking and cloud-based computing
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Basic experience with software tools/scripting (e.g., Matlab, Python, etc.)
Strong communication skills, both written and verbal, necessary to engage with technicians, production management, product development, planning, purchasing, regulatory, inspection, customer support, and clinical marketing organizations
Advanced skills with desktop software applications (Excel, PowerPoint, Word, etc.)
Basic knowledge of process controls, including Six-Sigma, CPk, etc.
High level of personal initiative, including ownership and leadership, to influence product design to improve reliability, robustness, and performance
Troubleshooting ability to systematically and effectively break down a system or process into subparts to identify failures and troubleshoot to component level
Knowledge and execution of Good Manufacturing Practices (GMP)
Excellent documentation skills and high standards for instructional clarity/accuracy
High energy and genuine excitement to learn and get to the bottom of problems
Nice to have:
MS degree in an engineering discipline listed above
Prior experience working in an FDA/ISO regulated environment
Prior experience with Documentation and production control systems: Agile, SAP, MES
Prior experience in development of: Matlab, Python
Demonstrated ability to effectively design experiments, solve problems, and implement them in manufacturing
Expert knowledge (black-belt) of process controls, including Six-Sigma, CPk, etc.
Prior experience evaluating/managing suppliers, of both custom and COTS parts
Experience in Just-In-Time, Demand Flow Technology, and Lean Manufacturing techniques
About the Company
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, with technologies like the da Vinci surgical system and Ion transforming how care is delivered for millions of patients worldwide. The company is a team of engineers, clinicians, and innovators united by the purpose to make surgery smarter, safer, and more human, helping care teams perform with greater precision and patients recover faster.
