Full-Time

Senior Supplier Quality Engineer

Confirmed live in the last 24 hours

PROCEPT BioRobotics

PROCEPT BioRobotics

501-1,000 employees

Develops robotic solutions for BPH treatment

Robotics & Automation
Healthcare

Compensation Overview

$120k - $151kAnnually

+ Annual Bonus + Equity/RSUs

Senior

No H1B Sponsorship

San Jose, CA, USA

Onsite position in San Jose, CA.

Category
QA & Testing
Manual Testing
Quality Assurance
Required Skills
Minitab
Requirements
  • 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, and the EU Medical Device Directive.
  • Lead auditor credentials for QSR, ISO, or MD SAP are desired.
  • 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.
Responsibilities
  • Conduct supplier assessments and audits to evaluate their capabilities, processes, and quality management systems to meet Procept and regulatory requirements.
  • Assist in the selection and qualification of new suppliers based on established procedures.
  • Develop periodic reports on supplier performance (scorecards). Establish and maintain periodic reviews with suppliers on their performance, and improvement plan.
  • Maintain detailed records of supplier audits, quality performance, and corrective action plans.
  • Report on supplier quality performance during cross-functional meetings and provide recommendations for improvement.
  • Create supplier quality reports, including analysis on defect trends, root causes, and long-term resolutions.
  • Ensure effective implementation of corrective actions and track results to ensure continuous improvement.
  • Lead resolution of supplier related non-conformances using problem solving tools (8D, Fishbone, 5 WHY’s, etc.).
  • In-depth understanding of manufacturing processes, including machining, fabrication, casting, injection molding, and assembly processes.
  • Ability to assess the quality impact of supplier manufacturing changes and deviations.
  • Must have excellent problem-solving abilities using systemic, logical, and sequential approaches and provide technical oversight for issue/problem resolution activities.
  • Comprehensive knowledge of TMV’s, process and product validations (i.e., IQ, OQ, PQ). Ability to independently execute supplier process validation.
  • Advanced knowledge of quality management tools, including, but not limited to (SPC, FMEA, MSA, DOE, and Quality Systems).
  • 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.

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.

Help us improve and share your feedback! Did you find this helpful?