Job Description

Primary Function of Position

You will be responsible for supporting SW/electrical/networking-related parts of the dV5 Tower (VSC) as they move from design to NPI and into manufacturing. This position is highly collaborative, and strong communication/presentation skills are fundamental to successful partnerships with engineering, production and management teams.

Essential Job Duties

• Take ownership of various Vision Cart mfg processes and overall analysis of design.
• Provide critical DFM (Design For Manufacturability) input to development teams for electrical-based sub-assemblies that are part of dV5 Digital functionality.
• Provide suggested process & product improvements using supporting data.
• Resolve failures of varying complexity, of both process and hardware nature.  Identify specific root cause, and implement solutions to improve yield/manufacturability.
• Employ/implement preventive measures to reduce failures.
• Understanding of some error codes, P values, UID test functions.
• Utilize knowledge of assembly/parts, suppliers, mfg and test processes.
• Assist with execution of purges and other major quality control processes for production, when product defects are identified.
• Support/suggest cost reduction improvements to design and other groups.
• Own and execute minor/local Production Process Qualification (PPQ) validations.  Assists 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, CAPAs, Cost reduction, etc.  Established good working relationships with close functions (Production, Quality Eng, Design Eng, Supplier Eng, etc.)
• Assist with project team coordination and task assignments.
• Present data and solutions at project team meetings or wider audience forums.
• 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, trend charts
• Regularly use statistical tools independently to drive data metric reporting and process improvements.
• Participate in risk analysis project teams whose intentions are to identify compliance gaps that may affect yields and quality metrics.  Understands implications of lifecycles, how they are used in product development.
• May occasionally mentor entry level or intern engineers for line support and troubleshooting.
• May informally supervise the work of technicians, document specialists, or interns
• Performs other duties as required.

Qualifications

Required Skills and Experience

• Minimum 3+ years experience in a manufacturing or design-related role
• Basic engineering principles and analysis techniques
• Solid understanding of computer architecture, including basic understanding of how SW runs on distributed nodes in system.
• Solid understanding of computer networking, including cloud-based computing
• Basic experience with software tools/scripting (eg. 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, confidence 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.

Required Education and Training

• Minimum BS degree in Computer Science/Eng, Electrical Eng, Mechanical Eng, Biomedical Eng or other similar field.

Preferred Skills and Experience

• 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 customer and COTS parts.
• Experience in Just-In-Time, Demand Flow Technology, and Lean Manufacturing techniques.