Manager, Supplier Engineering

Team: Operations

Location: San Jose, CA

Commitment: Full-Time

Workplace Type: onsite

Salary:

What Your Day-To-Day Will Involve:

• Lead Supplier Engineering (SE) team to complete project/ part qualification deliverables including:  Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis.
• Manage Supplier Engineering resources, projects, key operational deliverables and program metrics. Optimize and balance SE workload to optimize talent utilization, work content and priorities.
• Own and manage the overall portfolio of SE work content, including part qualifications, sustaining activity, cross-functional project support and workflow efficiency improvements.
• Identify supplier development opportunities and partner with Supplier Quality and Strategic Sourcing to develop and execute supplier development plans.
• Manage overall portfolio of Supplier Change Notifications (SCNs), including manufacturing process changes, material changes, facility moves, new equipment qualifications, and new line validations. Track SCN metrics for timely completions and assess impact on business requirements on a continual basis.
• Partner with Supplier Quality to investigate and address trends in Non-Conforming Material Reports (NCMRs) and support implementation of corrective / preventive actions for purchased parts.
• Manage and coordinate problem solving and root cause identification for parts not meeting requirements or specifications.
• Review and approve supplier protocols, qualification reports. Release documentation and reports in Change management systems; Engineering Change Order (ECO).
• Partner with Supply Chain to address supplier capacity constraints. Execute projects for capacity expansion, qualification of additional tooling or manufacturing lines to meet target business plan capacity.
• Work with Supply Chain and suppliers to identify opportunities and execute projects for cost reductions.
• Partner with suppliers to continually improve their manufacturing process performance using a collection of best practices in Six Sigma, Lean, SPC.
• Partner with R&D and suppliers to support Design for Manufacturability (DFM) activities by engaging suppliers early in the development cycle to provide feedback on part designs and specifications.
• Effectively prioritize and advance multiple concurrent projects and tasks.
• Research and recommend new technologies to improve reliability, efficiency and contribute to cost reduction.
• Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product quality and support regulatory compliance.
• Understand and adhere to the PROCEPT BioRobotics Quality and EHS policies.
• Travel to supplier locations, domestic and international as needed (approx. 25% travel anticipated).

The Qualifications We Need You to Possess:

• BS in Engineering or equivalent with a minimum of 8 years’ experience. At least 2 years of management or supervisory experience managing technical teams.
• Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities.
• Ability to interpret and understand the impact of purchased part changes like alternate raw material change, supplier process change, supplier tooling change, etc. to the internal manufacturing process and design, and develop, implement/execute qualification test plans.
• Ability to read and interpret detailed mechanical drawings (GD&T) and communicate technical information.
• Experience working in a structured design process such as ISO9000 or FDA QSR, knowledge of regulatory approval process and requirements.
• Ability to work in a cross functional environment, lead meetings, follow up on action items and deadlines. Escalate issues when necessary.
• Ability to travel 25% to suppliers on an as needed basis – domestic and international.
• Experience in leading highly technical projects in a cross functional environment both internally and with CMs/Suppliers.
• Extensive experience with root cause analysis and problem solving for both technical and process issues.
• Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003 or ISO9001 and EN46001.
• Basic working knowledge of CAD (SolidWorks or other) software.
• Prior experience in the medical device industry is preferred.

Supervisory Responsibilities:

• Directly manage a team of Supplier Engineers and/or technicians.
• Coach and mentor team members through technical, quality, and supplier challenges.
• Mentor engineers on quality and business processes.
• Manage priorities to meet business requirements. Day to day workload management. Supplier Engineering resource management.
• Performance management. Mentor and foster career growth for direct reports.