Full-Time

Senior Business Systems Analyst

Confirmed live in the last 24 hours

Penumbra Inc

Penumbra Inc

1,001-5,000 employees

Develops healthcare technology for vascular conditions

Hardware

Senior

Alameda, CA, USA

Required Skills
Communications
Requirements
  • Bachelor’s degree in engineering, computer science, or related discipline
  • 12+ years related experience in medical device, pharmaceutical, or FDA-regulated industry
  • Advanced knowledge of Quality Engineering Principals and Regulatory Environment
  • Experience with regulated software installation, configuration, validation, and maintenance
  • Expert knowledge of GAMP guidelines, 21 CFR Part 11, and FDA requirements
  • Strong oral, written, and interpersonal communication skills
  • Strong leadership skills with ability to work in a cross-functional team
  • Excellent organizational skills and ability to prioritize assignments
Responsibilities
  • Assure implementation, maintenance, and obsoletion of validated computerized systems in compliance
  • Lead projects and ensure effective communications with the business
  • Work on multiple projects, create documentation, and adhere to Quality Management System
  • Manage deviation process during testing and resolve deviations
  • Gather, understand, prioritize, and define business requirements
  • Provide quality support to development, engineering, and manufacturing functions
  • Facilitate internal quality reviews of requirements and drive business strategies

Penumbra, Inc. is renowned for its specialized focus on advanced healthcare technologies aimed at improving treatments for neuro and peripheral vascular conditions. Through its comprehensive product range, including breakthrough solutions like the REAL Immersive System and ACE Reperfusion Catheters, the company maintains a crucial role in enhancing patient care. Employees at Penumbra thrive in a culture dedicated to technical excellence and leadership in medical innovation, making it a highly regarded employer in the healthcare industry.

Company Stage

IPO

Total Funding

$3.4M

Headquarters

Alameda, California

Founded

2004

Growth & Insights
Headcount

6 month growth

5%

1 year growth

11%

2 year growth

19%