Manager, Supplier Engineer

PROCEPT BioRobotics•San Jose, CA

179d

About The Position

Responsible for ensuring suppliers meet Proceptâs requirements for quality, service, delivery, and cost. Drives suppliers to continuously improve business and manufacturing processes. Collaborates with Supplier Quality to evaluate and select suppliers. Guides R&D in choosing suppliers for new products and provides DFM input to new designs. Supports both NPI and on-going production, monitoring and working with suppliers to improve supplier performance. Executes detailed projects with suppliers to implement changes and improvements affecting quality, cost, capacity, risk, and sub-supplier management. The ideal Candidate possesses broad and deep manufacturing experience for processes such as assembly of medical devices, metals processing, machining, electronics, PCBA, plastic injection molding experience etc.

Requirements

BS in Mechanical Engineering or equivalent with a minimum of seven years experience.
Brings 1-2 years of managerial experience, leading other supplier engineers.
Experience in leading highly technical projects in a cross functional environment both internally and with CMs/Suppliers.
Experience with metals component manufacturing processes. Understanding of metallurgy, metals material selection, secondary processes such as heat treatment, anodizing, deburring, passivation etc.
Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities.
Extensive experience with root cause analysis and problem solving for both technical and process issues.
Basic working knowledge of CAD (SolidWorks or other) software.
Ability to read and interpret detailed mechanical drawings (GD&T) and communicate technical information.
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 case.
Experience working in a structured design process such as ISO9000 or FDA QSR, knowledge of regulatory approval process and requirements.
Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003 or ISO9001 and EN46001, including experience in auditing suppliers to these standards.
Ability to work in a cross functional environment, lead meetings, follow up on action items and deadlines. Escalate issues as and when necessary.
Ability to travel to suppliers on an as needed basis â domestic and international.

Nice To Haves

Prior experience in the medical device industry is preferred.

Responsibilities

Own and manage contract manufacturer and supplier qualifications of components, sub assemblies used in Aquablation capital equipment components, disposables and accessories as assigned. Typical parts include mechanical machined components, molded components, electronics, electro-mechanical and camera systems.
Assess and drive supplier qualification requirements and complete project/ part qualification deliverables including: Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis.
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 (ECO).
Develop supplier ramp readiness plans by judging business risk based on forecast, supplier capacity, quality performance, and process capability. Identify supply capacity gaps and develop plans to mitigate (capacity expansions, qualification of additional tooling, lines etc to meet target business plan capacity).
Manage supplier changes (for mechanical parts/assemblies) including manufacturing process changes, production optimization, facility changes, new equipment qualification, and new line validations.
Work with suppliers to execute cost reductions, capacity improvements, and risk mitigation.
Generate key metrics for the suppliers, and continually drive for timely achievement of those metrics.
Drive suppliers to continually improve their manufacturing process performance to meet Proceptâs requirements for supplier excellence using a collection of best practices in project management, Six Sigma, Lean, SPC and negotiation. Lead these efforts without managerial guidance at several suppliers simultaneously.
Investigate and drive rework, corrective actions for purchased part raw material non-conformance
Work closely with supplier quality team to develop and implement corrective and preventive actions for supplier processes by driving supplierâs investigations and root cause analysis.
DFM by engaging suppliers early in development cycle to provide feedback regarding manufacturability improvements in the designs prior to production.
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.
May require up to 20% travel, domestic and international.