Full-Time

Quality Engineer III

Confirmed live in the last 24 hours

Penumbra Inc

Penumbra Inc

1,001-5,000 employees

Develops medical devices for vascular conditions

Biotechnology
Healthcare

Compensation Overview

$109.8k - $145.9kAnnually

Mid

Alameda, CA, USA

This position is onsite in Alameda, CA.

Category
QA & Testing
Quality Assurance
Required Skills
Word/Pages/Docs
Excel/Numbers/Sheets
Requirements
  • Associate’s or Bachelor's degree in Engineering, a Life Science or a related field with 3+ years of quality engineering or relevant experience, preferably in a medical devices environment, or equivalent combination of education and experience
  • Familiarity with QSR, ISO, and other applicable regulations and laws required
  • Excellent verbal, written, and interpersonal communication skills required
  • Leadership skills desired
  • Proficiency with MS Word, Excel, and PowerPoint required
Responsibilities
  • Support Commercial Operations and Manufacturing activities such as Incoming/In-process/Final Inspections, NCRs, CAPAs, Engineering Change Orders, Control Chart Investigations, Deviation Authorizations, and Equipment sustaining activities.
  • Support assigned manufacturing product lines and perform failure analyses and defect investigations as appropriate.
  • Execute and collaborate on Continuous Improvement efforts.
  • Execute and support supplier activities such as Second Source Qualifications, Supplier Changes, and SCARs.
  • Interface with other engineering departments within the company, and suppliers on quality related issues.
  • Collaborate and/or help lead in the development of manufacturing documentation.
  • Design, improve and support Test Methods, Testing Equipment and TMVs.
  • Recommend revisions to specifications, acceptance criteria, and manufacturing documentation to improve quality of product and/or Manufacturing Operations.
  • Provide guidance to junior Quality Engineers in support of departmental functions.
  • Perform responsibilities required by the Quality System and other duties as assigned or requested.
  • Ensure other members of the department follow the QMS, regulations, standards, and procedures.
  • Perform other work-related duties as assigned.

Penumbra Inc. specializes in creating medical devices aimed at treating neurovascular and peripheral vascular conditions. Their products include a variety of devices for neuro interventions, such as the Penumbra System and the Penumbra SMART COIL, which are used to address issues like stroke. For peripheral vascular diseases, they offer the Indigo System and related devices. These products are designed to assist healthcare professionals in hospitals and clinics, primarily in Europe and the Americas. Penumbra differentiates itself from competitors by focusing on advanced solutions tailored for specific medical needs and by investing in ongoing research and development to enhance their offerings. The company's goal is to provide effective medical devices that improve patient outcomes in the fields of neurology and vascular surgery.

Company Stage

IPO

Total Funding

$116.7K

Headquarters

Alameda, California

Founded

2004

Growth & Insights
Headcount

6 month growth

5%

1 year growth

10%

2 year growth

20%
Simplify Jobs

Simplify's Take

What believers are saying

  • Penumbra's recent product launches, such as the BMX81 and BMX96 in Europe, demonstrate their commitment to expanding and improving their product portfolio.
  • Significant investments from firms like Jennison Associates LLC and Algert Global LLC indicate strong financial backing and confidence in Penumbra's growth potential.
  • The company's participation in high-profile conferences like the Truist Securities MedTech Conference and the William Blair Growth Stock Conference highlights its industry recognition and thought leadership.

What critics are saying

  • The highly competitive medical device market requires Penumbra to continuously innovate to maintain its market position.
  • Regulatory challenges and the need for CE Marks and FDA approvals can delay product launches and impact revenue.

What makes Penumbra Inc unique

  • Penumbra's focus on both neurovascular and peripheral vascular conditions sets it apart from competitors who may specialize in only one area.
  • Their continuous investment in R&D ensures that they remain at the forefront of medical device innovation, particularly with recent launches like the Lightning Flash 2.0 CAVT technology.
  • Penumbra's global reach, serving healthcare providers in over 100 countries, provides a broad market presence that many competitors lack.

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