Sr. Quality Engineer at Penumbra Inc

Roseville, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor’s degree in Engineering, a Life Science or related field with 5+ years of relevant experience, including experience in Quality Assurance and ISO, or an equivalent combination of education and experience
Advanced degree preferred
Experience in auditing, design review, sterilization, project management, and/or product development is highly desired
Passion for detailed analysis and problem solving
Knack for solving quality control problems effectively
Desire to be part of a great team and represent Quality Engineering on cross-functional technical teams
Ability to present issues, plans, and objectives in a clear, compelling way, both orally and in writing
Versatility, flexibility, and willingness to work within changing priorities
Broad knowledge of applicable regulations and standards, e.g., QSR, ISO 13485
Solid knowledge of sterilization, biocompatibility, and transportation and shelf-life standards
Working knowledge of data collection, data analysis, evaluation, and scientific methods
R&D or new product development experience helpful
ASQ CQE preferred
Ability to work in general office, laboratory, and cleanroom environments
Business travel from 0% - 10%
Potential exposure to blood-borne pathogens
Ability to lift and move up to 25 pounds
Ability to move between buildings and floors
Ability to remain stationary and use a computer or other standard office equipment for extensive periods
Ability to read, prepare emails, produce documents and spreadsheets
Ability to move within the office and access file cabinets or supplies
Ability to communicate

Responsibilities

Represent Quality Engineering on cross-functional teams, interfacing among multiple departments and teams such as Manufacturing, QC, R&D, Regulatory Affairs, Operations/Planning, and Marketing
Evaluate, analyze, and continuously improve manufacturing processes, quality controls, and engineering systems for assigned product lines
Own or review Engineering Change Orders on assigned projects and product lines
Plan, design, and implement test/inspection methods, including test/inspection equipment, to achieve product quality control objectives
Partner with suppliers to continually improve technical processes, reliability, and quality controls to meet Penumbra's quality standards
Take the lead on risk analysis and documentation
Lead or participate in project teams, coordinating the quality efforts to meet project objectives
Plan, schedule, and execute engineering project work to meet business and quality objectives
Provide leadership and guidance to ensure assigned projects and product lines are compliant with the quality system and regulations
Lead nonconforming report investigations and recommend appropriate corrective actions
Identify the need for Corrective Action Preventative Action (CAPA). Initiate, implement, and close CAPAs
Design experiments and tests, and apply statistical rationale to analyze and interpret engineering test data
Provide leadership and mentoring to more junior staff. May supervise junior engineers

Skills

Quality Engineering

Process Development

Supplier Development

Manufacturing Processes

Engineering Change Orders

Test Methods

Inspection Equipment

Risk Analysis

CAPA

Statistical Analysis

DOE

Nonconforming Investigations

Corrective Actions

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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