Quality Engineer III at Penumbra Inc

Alameda, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

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
Excellent verbal, written, and interpersonal communication skills
Proficiency with MS Word, Excel, and PowerPoint
Leadership skills desired
Ability to work in general office, laboratory, and cleanroom environments; lift and move up to 25 pounds; stand, walk, sit, reach, use a computer for extended periods; specific vision abilities including close vision, distance vision, color vision, peripheral vision, and depth perception

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

Skills

Key technologies and capabilities for this role

NCRsCAPAsEngineering Change OrdersControl Chart InvestigationsDeviation AuthorizationsFailure AnalysisDefect InvestigationsContinuous ImprovementSCARsTest MethodsTMVsSupplier QualificationsQuality SystemQMS

Questions & Answers

Common questions about this position

What education and experience are required for the Quality Engineer III position?

A minimum of an 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, is required.

What key skills are needed for this role?

Familiarity with QSR, ISO, and other applicable regulations and laws is required, along with excellent verbal, written, and interpersonal communication skills, proficiency with MS Word, Excel, and PowerPoint, and leadership skills are desired.

What is the work environment like for this position?

The role involves general office, laboratory, and cleanroom environments, with some lifting up to 25 pounds, frequent standing, walking, sitting, reaching, computer use, and specific vision abilities.

Is this a remote position, or does it require on-site work?

This information is not specified in the job description.

What salary or compensation is offered for the Quality Engineer III role?

This information is not specified in the job description.

What does the company culture or team environment look like?

The role involves working with collaborative teams, interfacing with other engineering departments and suppliers, providing guidance to junior Quality Engineers, and ensuring the department follows the Quality Management System.

What makes a strong candidate for this Quality Engineer III position?

Candidates with 3+ years in medical devices, familiarity with QSR and ISO regulations, strong communication skills, proficiency in MS Office, and leadership experience stand out, especially those who can independently handle advanced quality issues and guide junior engineers.

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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