Staff Supplier Engineer (Contract Manufacturing) San Jose, CA

Company: BioRobotics
Location: San Jose
Posted on: February 1, 2025

Job Description:

Company OverviewEmbark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. We 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, and 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.The Opportunity That Awaits You:Join PROCEPT BioRobotics, a pioneering surgical robotics company revolutionizing urology care with transformative technologies like the FDA-cleared AQUABEAM Robotic System. This role offers the chance to work on cutting-edge innovations, driving supplier excellence, and advancing groundbreaking medical devices that improve patient outcomes. You'll collaborate with cross-functional teams, lead supplier projects, and contribute to impactful initiatives in quality, cost, and capacity improvements. With a focus on developing Suppliers and Contract Manufacturers of sub-assemblies, components, electronics, PCBA, and Cables manufacturing in a dynamic work environment, this position is perfect for engineering professionals passionate about shaping the future of Robotic healthcare technology.This role will be instrumental in realizing the Supplier Engineering Vision to Build a world-class Supplier Engineering function enabled by strong supplier relationships, focused on serving Supply Chain, Operations, and R&D to ensure components and assemblies for Procept BioRobotics are delivered with Quality, In Time, In Full and at High Value.What Your Day-To-Day Will Involve:

• Own and manage Contract Manufacturer and supplier qualifications of assemblies, sub-assemblies, components used in Aquablation Capital Equipment, Disposables, and Accessories, Surgical Drapes as assigned. Typical parts in these systems include mechanical machined components, welded, 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.
• Select contract manufacturers and suppliers, develop and qualify their manufacturing capacity.
• Manage and coordinate problem-solving and root cause identification for parts not meeting requirements or specifications. Using in-depth professional knowledge, acumen, concepts, and company objectives to develop and resolve complex models and procedures. Provides solutions to issues in creative and effective ways. Understands the interrelationships of different disciplines.
• Review and approve supplier protocols, master validation plans and reports (MVP, MVR), qualification reports. Release documentation and reports in Change management systems (ECO).
• Direct the application of existing principles and guide the development of new policies and ideas as pertaining to Supplier Engineering, Manufacturing Engineering. Recognizes opportunities for improvements and drives changes to business processes, procedures that have a tactical impact on business.
• Develop CM/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 CM/supplier changes (for mechanical parts/assemblies) including manufacturing process changes, production optimization, facility changes, new equipment qualification, and new line validations.
• Select the right process and supplier for the part, considering long-term fit and total cost of ownership.
• Work with suppliers to execute cost reductions, capacity improvements, and risk mitigation. Networks with key contacts outside own area of expertise. Adapts style and uses persuasion in delivering messages that relate to the wider firm business.
• Frequently advises others internally at Procept or externally at suppliers on complex matters. May be accountable through the team for delivery of tactical business targets.
• Assess and qualify alternate raw materials or alternate suppliers to overcome supply chain shortages for continued or uninterrupted supply of mechanical parts/sub-assemblies by understanding the impact on overall product design and/or process.
• Build, own, and relentlessly pursue a vision for developing suppliers. This may involve visits and teleconferences with domestic and overseas partners.
• 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 PROCEPT's 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 the supplier quality team to develop and implement corrective and preventive actions for supplier processes by driving supplier's investigations and root cause analysis.
• DFM by engaging suppliers early in the development cycle to provide feedback regarding manufacturability improvements in the designs prior to production.
• Influence and guide R&D in choosing suppliers by determining selection criteria for preferred suppliers and leading the team effort to evaluate preferred suppliers.
• 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.The Qualifications We Need You to Possess
  • BS in Mechanical Engineering or equivalent with a minimum of eight years' experience.
  • Experience in leading highly technical projects in a cross-functional environment both internally and with CMs/Suppliers.
  • 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.
  • Experience in typical assembly processes such as welding, machining, bonding, etc.
  • 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.
  • Ability to work in a cross-functional environment, lead meetings, follow up on action items and deadlines. Escalate issues as and when necessary.The Qualifications We Would Like You to Possess
    • Prior experience in the medical device industry, contract manufacturing management is preferred.
    • 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.
    • Basic working knowledge of CAD (SolidWorks or other) software.
    • Ability to travel to suppliers on an as-needed basis - domestic and international.
    • Onsite at San Jose, CA.For US-Based Candidates OnlyWork Authorization Status: Citizen / Permanent ResidentFor this role, the anticipated base pay range is $162,000-210,000 per year.Plus, eligibility for an annual bonus and equity/RSUs.Understanding PROCEPT's CultureAt PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity, and conviction in the power of technology will transform the lives of our patients and providers.And this doesn't happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept's history, jam-packed interactive sessions with executive leadership and a crash course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports, and broadens.We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances.An opportunity at PROCEPT BioRobotics won't just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!BENEFITS OF WORKING AT PROCEPT!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 well-being 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, well-being benefits, flexible or paid time off, paid parental leave, paid holidays, and many more!EQUAL EMPLOYMENT OPPORTUNITY STATEMENTPROCEPT BioRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.PAY RANGE TRANSPARENCYProcept is committed to fair and equitable compensation practices. The pay range(s) for this role is listed below and represents base salary range for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, relevant certifications and training, and specific work location. Based on the factors above, Procept utilizes the full width of the range. The total compensation package for this position may also include eligibility for annual performance bonus, equity, and the benefits listed above.WORK ENVIRONMENTWe'll provide you training for, and ask you to maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. We would also ask you to understand and adhere to the PROCEPT BioRobotics Quality & EHS policies.
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Keywords: BioRobotics, Cupertino , Staff Supplier Engineer (Contract Manufacturing) San Jose, CA, Engineering , San Jose, California