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Form of workPROCEPT 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
At PROCEPT BioRobotics you will have an opportunity to contribute and greatly support our continuous improvement philosophy by being part of our Quality Engineering team. This position has a unique impact on the quality and reliability of our devices. You will work with cross-functional teams to maintain and improve the Quality System within the requirements of FDA's Quality System Regulation (QSR), ISO 13485 (ISO) and EU MDR. Being detail and solution oriented, proactive, and self-managed will assist in the success of this position.
- Provide support to execute Supplier Quality projects, including supplier change requests, process improvements, new supplier qualification, and receiving inspection.
- Assist in resolution of supplier related non-conformances using problem solving tools (8D, Fishbone, 5 WHY's, etc.). Must have excellent problem-solving abilities using systemic, logical, and sequential approaches and provide technical oversight for issue/problem resolution activities.
- Use lean and six sigma tools to drive process and product variance reduction.
- Lead assessments and audits to evaluate supplier capability to meet Procept and regulatory requirements.
- Assist with implementation of Supplier Change Requests.
- Participate in failure investigations to analyze internal system or process failures and to implement corrective and preventive action.
- Lead or participate in the continuous improvement of business processes and tools.
- Participate in supplier material related processes which include coordination of MRB activities to ensure the timely assessment of potential non-conforming products.
- Support continuous product and process improvement through detailed failure analysis for nonconformance's, and investigates, develop, and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions.
- Understand and adhere to the PROCEPT BioRobotics and EHS policies.
- 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.
- Bachelor's degree preferably in an engineering or scientific discipline.
- 5+ years experience working in manufacturing of finished medical device or related industry.
- Working knowledge of the FDA Quality System Regulation, ISO 13485, ISO 14971, ISO10993, ISO 11135, and the EU Medical Device Directive is a plus.
- Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
- Lead auditor credentials for QSR, ISO, and MD SAP are desired.
- Strong interactive skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, and project management.
- (Cognitive Skills) Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
- Knowledge of probability, statistical quality control and design of experiments, Minitab proficiency preferred.
- Knowledge of geometric design and tolerance (GD&T) and gage design tolerance preferred.
- Working knowledge of process and product validations (i.e., IQ, OQ, PQ).
- 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 safely within the facility. The employee may occasionally lift and/or move up to 15 pounds.
- While performing the duties of this job, the employee regularly works in an office environment.
For US Based Candidates Only
For this role, the anticipated base pay range is $92,000-$132,000 a year.
PROCEPT BioRobotics is committed to fair and equitable compensation practices and we aim to provide employees with total compensation packages that are market competitive. While our ranges are posted, the exact base pay offered for this role will depend on various factors, including but not limited to the successful candidate's qualifications, skills, experience, location or comparison to other employees already in similar roles. In addition to base salary, our positions are eligible for variable compensation through one of our incentive plans as well as equity compensation based on role and level. PROCEPT also offers a comprehensive suite of benefits including, but not limited to, health insurance plans, ESPP, 401k retirement savings plan with a company match, and paid time off programs. All compensation and benefits programs are subject to the discretion of the company.
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