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Full-Time

Quality Engineer

Nonconforming Materials System

Posted on 10/23/2024

PROCEPT BioRobotics

PROCEPT BioRobotics

501-1,000 employees

Develops robotic solutions for BPH treatment

Biotechnology
Healthcare

Compensation Overview

$92k - $116kAnnually

+ Annual Bonus + Equity/RSUs

Mid

No H1B Sponsorship

San Jose, CA, USA

Position requires onsite presence in San Jose, CA.

Category
QA & Testing
Manual Testing
Quality Assurance
Required Skills
Minitab
Word/Pages/Docs
Data Analysis
Excel/Numbers/Sheets
Requirements
  • Bachelor of Science in Engineering or combination of relevant education and experience.
  • 3 – 6 years relevant experience in medical device manufacturing.
  • Experience in medical device manufacturing and with strong working knowledge of cGMPs.
  • Manufacturing or Quality Engineering experience.
  • Experience with Non conforming material software tools.
  • Experience with development and authoring procedures (SOPs, Work Instructions).
  • Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred).
  • Demonstrated knowledge of Project Management principles.
  • Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
  • Strong organizational skills, detail oriented. Exceptional oral and written communication skills.
  • Ability to collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.)
  • Ability to work to a deadline and to handle multiple tasks simultaneously.
  • Experience with Microsoft Office including Microsoft Word, Excel, PowerPoint, and Project.
Responsibilities
  • NCMR QE will help the NCMR process owner with maintaining the NCMR process in Propel, trend NCMR data, manage the overall NC workflow process, and maintain NCMR metrics data integrity.
  • Conduct weekly NCMR review meeting to review status of open NCMRs.
  • Provide NCMR trend analysis and reported during periodic management Review meetings.
  • As NCMR Propel Coordinator this role is responsible for supporting the NC process workflow and re-assigning NCMR approvers as required.
  • Assist NCMR approvers by ensuring overall information documented on the NC including supporting documents are accurate, relevant, and complete.
  • Support and back up to MRB Coordinator managing, labeling, and maintaining the quarantined materials as they move in and out of the MRB Cage, and performing any enterprise resource planning (ERP) transactions.

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 urologists and healthcare facilities, allowing for improved patient outcomes and more efficient surgical procedures. Unlike competitors, PROCEPT BioRobotics focuses on providing predictable results and reducing 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

$637.7M

Headquarters

Redwood City, California

Founded

2009

Growth & Insights
Headcount

6 month growth

10%

1 year growth

37%

2 year growth

112%
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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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