Quality Engineer II - Electronics at Penumbra Inc

Alameda, California, United States

Penumbra Inc Logo
$95,000 – $127,000Compensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
ElectronicsIndustries

Requirements

Candidates should possess an Associate’s or Bachelor’s degree in Engineering, a Life Science, or a related field, and have at least 2+ years of quality engineering or relevant experience, preferably in a medical devices or regulated industry environment, or an equivalent combination of education and experience. Familiarity with QSR, ISO, and other applicable regulations and laws is required, along with experience with Electronic devices and or PCBAs, and excellent verbal, written, and interpersonal communication skills.

Responsibilities

The Quality Engineer II will develop and implement quality system elements to ensure the high-quality level of new and existing products as well as their compliance with applicable regulations and standards. They will collaborate in the development and qualification activities for new and existing products, develop testing and inspection methodology and documentation, collaborate on Quality Objective teams, design and install QC process sampling systems, perform failure analyses and defect investigations, analyze production limitations and standards, recommend revision of specifications, interface with engineering departments, customers, and suppliers on quality related issues, collaborate in the development of standard operating procedures, facilitate and perform internal audits, and ensure other members of the department follow the QMS, regulations, standards, and procedures. They will also understand relevant security, privacy, and compliance principles and adhere to applicable regulations, standards, and procedures.

Skills

Quality Management System
Statistical Techniques
Failure Analysis
Defect Investigation
Internal Audits
QC Sampling
Inspection Methodology
Testing Equipment

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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