Quality Engineer II at Penumbra Inc

Roseville, California, United States

Penumbra Inc Logo
Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical DevicesIndustries

Requirements

  • 2+ years experience in a manufacturing or laboratory environment required; medical device experience preferred; injection molding & tooling development preferred
  • Bachelor’s or Master's degree in an engineering or scientific discipline required
  • Experience on production lines manufacturing high performing catheter products
  • Independently provide knowledge of Penumbra Quality Management System as it pertains to sustaining manufacturing operations as well as dealing with supplier quality and developing new products
  • Clear and concise written and oral communication skills preferred
  • A strong drive to work on products that have a meaningful impact on peoples' lives
  • Proven ability to thrive in a fast-paced work environment where navigating grey areas is a welcomed challenge
  • A passion for working in collaborative and dynamic teams with a feedback-rich culture

Responsibilities

  • Identify and drive areas of opportunity for process improvement, yield improvement, and cycle time reduction
  • Lead strategic plans for biocompatibility and sterilization for upcoming products
  • Determine root-cause of in-process quality assurance issues
  • Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures
  • Ensure other members of the department follow the QMS, regulations, standards and procedures
  • Perform other activities requiring knowledge of principles and techniques commonly employed in the specific area of projects

Skills

Quality Management System
Catheter Manufacturing
Process Improvement
Biocompatibility
Sterilization
Root Cause Analysis
Injection Molding
Supplier Quality
Yield Improvement
Cycle Time Reduction

Penumbra Inc

Develops medical devices for vascular conditions

About Penumbra Inc

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.

Alameda, CaliforniaHeadquarters
2004Year Founded
$116.7KTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
1,001-5,000Employees

Benefits

Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
401(k) Retirement Plan
401(k) Company Match
Paid Parental Leave
Paid Vacation
Paid Sick Leave
Paid Holidays

Risks

Recent layoffs in the Immersive Healthcare division may indicate financial strain.
The EMBOLIZE trial could divert resources from core product lines.
Regulatory challenges in Europe may impact sales of new products like BMX81 and BMX96.

Differentiation

Penumbra offers a comprehensive range of neuro and peripheral vascular devices.
The company focuses on innovative solutions for stroke and neurovascular disease treatment.
Penumbra's global presence spans North America, Europe, Asia, and Australia.

Upsides

Growing demand for minimally invasive procedures aligns with Penumbra's product offerings.
The global neurovascular devices market is projected to grow at 8.5% CAGR until 2030.
Penumbra's European launch of BMX81 and BMX96 expands its market presence.

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