Quality Engineer II at Penumbra Inc

Alameda, California, United States

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Not SpecifiedCompensation

Junior (1 to 2 years), 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

Key technologies and capabilities for this role

QMSBiocompatibilitySterilizationRoot Cause AnalysisProcess ImprovementYield ImprovementCycle Time ReductionSupplier QualityInjection MoldingTooling DevelopmentCatheter Manufacturing

Questions & Answers

Common questions about this position

What is the starting base salary for the Quality Engineer II position?

The starting base salary is $95,000/year - $127,000/year, with individual compensation varying based on factors such as performance, skill level, competencies, work location, and shift.

Is this Quality Engineer II role remote or on-site?

The role is based in Alameda, CA, in a general office environment with business travel from 0% - 10%. Remote work is not specified.

What experience and skills are required for the Quality Engineer II role?

Candidates need 2+ years experience in a manufacturing or laboratory environment (medical device experience preferred), knowledge of Penumbra's Quality Management System, experience on production lines manufacturing catheter products, and a Bachelor’s or Master's degree in an engineering or scientific discipline.

What is the company culture like at Penumbra for this role?

Penumbra offers a collaborative teamwork environment where learning is constant, performance is rewarded, and there is a passion for working in collaborative and dynamic teams with a feedback-rich culture.

What makes a strong candidate for the Quality Engineer II position?

Strong candidates have 2+ years in manufacturing or lab environments (especially medical devices), a drive to impact lives, ability to thrive in fast-paced settings, clear communication skills, and a degree in engineering or science.

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