Manager, Supplier Engineering

PROCEPT BioRobotics • San Jose, CA

9d

About The Position

Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.

Are you ready to embark on an exciting journey that will revolutionize the way men suffering from BPH are treated? Join us as a Manager, Supplier Engineering and be at the forefront of partnering with our suppliers and contract manufacturers that supply high value and high-quality components and sub-assemblies for our groundbreaking Aquablation Robotic System.
The Supplier Engineering (SE) Manager is responsible for leading a team of supplier engineers, setting priorities and guiding execution of component qualification activities. The SE Manager is responsible for ensuring suppliers and contract manufacturers meet PROCEPT BioRobotics’ requirements for quality, delivery, service, and cost. The role partners closely with Quality, Operations, R&D, and Supply Chain in supplier evaluation and provides input to part specifications to improve manufacturability. The role balances hands-on technical leadership with managerial responsibilities, including supplier strategy development, execution and cross-functional influence. The role supports both on-going production and new components development, executes detailed projects with suppliers, leads supplier development and supports supply chain risk mitigation activities. The SE Manager possesses broad and deep manufacturing experience for processes such as electronics assembly (cables, PCBAs, etc.), metals processing, precision machining, plastic injection molding and contracted assembly of medical devices.

Requirements

• 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.

Nice To Haves

• Prior experience in the medical device industry is preferred.

Responsibilities

• 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).

Benefits

• PROCEPT’s health and wellness benefits for employees are second to none in the industry. As an organization, one of our top priorities is to maintain the health and wellbeing of our employees and their families. We offer a comprehensive benefits package that includes full medical coverage, wellness programs, on-site gym, a 401(k) plan with employer match, short-term and long-term disability coverage, basic life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and many more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level