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, Senior

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, such as the Penumbra System and the Indigo System, are designed for use in hospitals and clinics, helping healthcare professionals address issues like stroke and other vascular diseases. These devices work by providing advanced tools for interventions in neurology and vascular surgery, allowing for effective treatment options. Unlike many competitors, Penumbra focuses specifically on these specialized areas, ensuring their products are tailored to the needs of medical professionals in these fields. The company's goal is to continuously improve and innovate their medical devices to enhance patient care and support healthcare providers in delivering effective treatments.

Company Stage

IPO

Total Funding

$116.7K

Headquarters

Alameda, California

Founded

2004

Growth & Insights
Headcount

6 month growth

3%

1 year growth

10%

2 year growth

20%
Simplify Jobs

Simplify's Take

What believers are saying

  • Growing demand for minimally invasive procedures boosts Penumbra's advanced catheter technologies.
  • Increased healthcare spending in emerging markets opens new sales opportunities for Penumbra.
  • Rising prevalence of neurovascular diseases drives demand for Penumbra's innovative solutions.

What critics are saying

  • Increased competition in the neurovascular space could impact Penumbra's market share.
  • Regulatory challenges in Europe may delay product launches and affect revenue growth.
  • Recent layoffs in Immersive Healthcare suggest potential financial strain or strategic shifts.

What makes Penumbra Inc unique

  • Penumbra offers a comprehensive range of neuro and peripheral vascular devices.
  • The company has a strong global presence in over 100 countries.
  • Penumbra's products are designed for minimally invasive procedures, aligning with market trends.

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