PROCEPT BioRobotics is a surgical robotics company enabling better patient care by developing transformative solutions in urology. With an initial focus on BPH, the company’s AQUABEAM® Robotic System delivering Aquablation therapy, is the first FDA-cleared, automated surgical robot for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Aquablation therapy combines real-time, multi-dimensional imaging, automated robotics and heat-free waterjet ablation for targeted, controlled, and immediate removal of prostate tissue. Aquablation therapy offers predictable and reproducible outcomes, independent of prostate anatomy, prostate size or surgeon experience.
SUMMARY
Responsible for ensuring suppliers meet Procept’s 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 hands-on metal machining manufacturing experience and/or plastic injection molding experience along with skills to select and develop suppliers.
CORE RESPONSIBILITIES (Other duties may be required as assigned)
- Manage supplier changes 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.
- Complete project/ part qualification deliverables including: Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis.
- 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 team and 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.
- Implement corrective and preventive actions for supplier processes by driving supplier’s investigations and root cause analysis.
- Develop supplier ramp readiness plans by judging business risk based on forecast, supplier capacity, quality performance, and process capability.
- DFM by engaging suppliers early in 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.
- Communicate business and technical needs, status, results, and observations to operating, technical and business teams.
- 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.
QUALIFICATIONS (Education, Experience, Certifications)
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- BS in Mechanical Engineering or equivalent with a minimum of twelve years experience.
- Prior experience in the medical device industry is preferred.
- 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.
- Basic working knowledge of CAD (SolidWorks or other) software.
- 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.
- 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 travel to suppliers on an as needed basis – domestic and international.
PHYSICAL DEMANDS
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- To perform this duty the employee must have the ability to sit or stand at and operate a computer terminal and walk or travel within the facility. The employee may occasionally lift and/or move up to 50 pounds.
WORK ENVIRONMENT
- While performing the duties of this job, the employee is regularly working in an office environment.
- The employee will then occasionally be exposed to engineering labs, a machine shop, and manufacturing clean rooms. This environment is subject to moderate noise from machinery (IE machine shop equipment, the PROCEPT Aquablation unit, computer equipment, printers, etc.), for which proper hearing protection may be assigned and worn.
- The employee may be exposed to hazards including electrical sparking, water, and chemicals, for which proper protective equipment may be assigned and worn.
- COVID-I9 Vaccine Requirement: All PROCEPT BioRobotics employees must be vaccinated against the COVID-19 virus. The company will follow an accommodation process for medical or religious exemptions.