Full-Time

Document Control Specialist

Posted on 11/19/2024

PROCEPT BioRobotics

PROCEPT BioRobotics

501-1,000 employees

Develops robotic solutions for BPH treatment

Robotics & Automation
Healthcare

Compensation Overview

$72k - $90kAnnually

+ Annual Bonus + Equity/RSUs

Mid

No H1B Sponsorship

San Jose, CA, USA

Hybrid position requiring in-office presence.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
CAD
Word/Pages/Docs
SolidWorks
Excel/Numbers/Sheets
Requirements
  • 3+ years of document control experience in the medical device industry or related industry
  • Bachelor’s degree or equivalent combination of related education and experience required
  • Knowledge and understanding of Document Control standards, practices, and principles
  • Experience with databases and advanced knowledge of the Microsoft suite (i.e. Word, Excel, Visio, PowerPoint, etc.) and Adobe.
  • Basic working knowledge of CAD (SolidWorks) software
  • Effective written and oral communication skills
  • Effective time management and interpersonal skills
  • Demonstrates ability to perform detail-oriented work with a high degree of accuracy and the ability to multitask
  • Ability to work independently as well as collaboratively in a team environment
  • Ability to work proactively and effectively in a fast paced, high change environment
  • Flexible; adapts work style to meet organization needs
  • Demonstrated initiative and resourcefulness
  • Assumes responsibility and accountability for results
  • Committed to self-development and professional growth; solicits feedback from others
Responsibilities
  • Maintain and support all 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.
  • 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.
  • 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.
  • Create and maintain document templates, as needed, while ensuring continuous improvement.
  • Review, and comment on current document control systems improvements and ensure their proper implementation.
  • Use CAD (SolidWorks) to make simple redline changes to part drawings.
  • Maintain training compliance by updating training plans.
  • Work on assignments where judgment is required and making recommendations.
  • Support external standards library.
  • Provide support with internal and regulatory audits and inspections as required (i.e. CA, FDB, FDA and ISO).
  • Scan and clean documents in preparation for electronic and offsite storage archiving. Support the offsite storage program.
  • Work effectively within teams with rapidly changing priorities.
  • Take and document meeting minutes.
  • Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance.
  • Understand and adhere to the PROCEPT BioRobotics Quality & EHS Policies.

PROCEPT BioRobotics develops robotic solutions specifically for treating benign prostatic hyperplasia (BPH), a condition that affects many older men by causing prostate enlargement and urinary issues. Their main product, the AquaBeam Robotic System, utilizes Aquablation therapy, which combines real-time imaging, robotics, and waterjet technology to precisely remove prostate tissue in a minimally invasive manner. This system is designed for use by urologists and healthcare facilities, focusing on improving patient outcomes and making surgical procedures more efficient. Unlike competitors, PROCEPT BioRobotics emphasizes predictable results and reduced complications, which has led to their technology being recognized in clinical guidelines. The company's goal is to enhance the quality of life for patients suffering from BPH through advanced surgical solutions.

Company Stage

IPO

Total Funding

$319.1M

Headquarters

Redwood City, California

Founded

2009

Growth & Insights
Headcount

6 month growth

11%

1 year growth

33%

2 year growth

102%
Simplify Jobs

Simplify's Take

What believers are saying

  • Long-term data demonstrating the sustained benefits of Aquablation therapy enhances the company's reputation and supports its market position.
  • Significant investments, including $118 million in equity financing, provide the financial resources needed for global expansion and innovation.
  • FDA approval for investigating Aquablation therapy for prostate cancer opens new market opportunities and potential revenue streams.

What critics are saying

  • Ongoing investigations by law firms into possible securities fraud could damage the company's reputation and investor confidence.
  • The medical device market is highly competitive, and maintaining technological leadership requires continuous innovation and substantial investment.

What makes PROCEPT BioRobotics unique

  • PROCEPT BioRobotics specializes in Aquablation therapy, a unique minimally invasive treatment for BPH that combines real-time imaging, robotics, and waterjet technology, setting it apart from traditional surgical methods.
  • The company's focus on urology and the treatment of BPH allows it to develop highly specialized and effective solutions, unlike competitors with broader medical device portfolios.
  • The inclusion of PROCEPT's technology in clinical practice guidelines underscores its credibility and effectiveness, distinguishing it from less established competitors.

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