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
Do you want to be part of an innovative, cutting edge technology, robotic company that is changing how BPH is treated? Are you looking to be part of an enthusiastic, driven, passionate and challenging team, who continuously learns from one another? Are you looking to make a difference and learn? At PROCEPT BioRobotics you will have an opportunity to work with cross-functional teams to maintain the Document Control and Training programs within the requirements of FDA's Quality System Regulation (QSR), ISO 13485 (ISO) and other applicable regulations and standards. Being detail and solution oriented and proactive will assist in the success of this position.
- Support R&D projects by driving cross-functional communication, coordination related to completion of sprint goals in an AGILE/Scrum structure
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Support R&D project managers and engineers on routing documentation for approval and setting up relevant cross-functional meeting as needed
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Support new product development by maintaining and controlling company-controlled documentation as part of the Quality System including hard and soft copies; drawings, specifications, lab notebooks, Design History Files, corrective/preventative action, internal audits, Device History Record.
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Understand and demonstrate the ability to perform document control processes. Provide end-user assistance in the Engineering Change Order (ECO) processes and of the Product Lifecycle Management System.
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Analyze document changes for correctness and completeness. Ensure the correct and timely implementation of document control requests. Verify own work, check format and compliance with company templates.
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Create and maintain document templates, as needed, while ensuring continuous improvement.
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Review, and comment on current document control systems improvements and ensure their proper implementation.
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Use CAD (SolidWorks) to make simple redline changes to part drawings.
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Maintain training compliance by updating training plans.
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Work on assignments where judgment is required and making recommendations.
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Support external standards library.
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Work effectively within teams with rapidly changing priorities.
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Take and document meeting minutes.
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Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance.
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Understand and adhere to the PROCEPT BioRobotics Quality & 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.
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Bachelors degree in Engineering
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Knowledge and understanding of Document Control standards, practices, and principles
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Experience with databases and advanced knowledge of the Microsoft suite (i.e. Word, Excel, Visio, PowerPoint, etc.) and Adobe
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Effective written and oral communication skills
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Effective time management and interpersonal skills
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Demonstrates ability to perform detail-oriented work with a high degree of accuracy and the ability to multitask
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Ability to work independently as well as collaboratively in a team environment
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Ability to work proactively and effectively in a fast paced, high change environment
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Flexible; adapts work style to meet organization needs
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Demonstrated initiative and resourcefulness
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Assumes responsibility and accountability for results
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Committed to self-development and professional growth; solicits feedback from others
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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.
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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 25 pounds.
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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 $71,000-$98,000 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.
COVID-I9 Vaccine Requirement: As of August 19, 2021, all PROCEPT BioRobotics employees must be vaccinated against the COVID-19 virus. The company will follow an accommodation process for medical or religious exemptions.