Sr Quality Engineer - Electronics 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 Devices, ElectronicsIndustries

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, preferably in a medical devices’ or regulated industry environment
Advanced degree preferred
Experience with Process Failure Mode and Effects Analysis (PFMEA), sustaining projects, commercial medical device manufacturing, Non-Conformance Reports (NCRs), Failure Investigations, and Change Control
Experience in auditing, design review, sterilization, project management, and/or product development highly desired
Experience with Electronic devices and/or PCBAs
Experience with Contract Manufactured Electromechanical Medical device products

Responsibilities

Participate in the development and qualification activities for new and existing products
Lead and participate in project teams coordinating the quality efforts to design, develop, and continuously improve products. Plan, schedule, conduct, or coordinate detailed phases of the engineering work for projects with various scopes
Perform work which involves conventional engineering practice but may include a variety of complex features, such as conflicting design requirements, unsuitability of standard materials, and difficult coordination requirements
Design and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of equipment
Develop and validate measurement methods
Monitor design control to assure that new products meet guidelines, develop success measurements, and maintain currency with design control standards per regulatory and industry standards
Support developmental projects in the area of quality assurance
Analyze reports and returned products and recommend corrective and preventive action
Perform statistical analysis and determine the responsibility for products or materials that do not meet required standards and specifications
Participate in NCR or CAPA board as necessary
Assist in and perform QSR training
Support activities during FDA inspections, FDB inspections, and notified body audits
Participate in the development of standard operating procedures
Prepare documentation for inspection/testing procedures
Perform responsibilities required by the Quality System and other duties as assigned
Select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans
Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures
Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company
Ensure other members of the department follow the QMS, regulations, standards, and procedures
Perform other work-related duties as assigned

Skills

Quality Assurance

Design Control

Statistical Analysis

Product Qualification

Inspection Methods

Testing Procedures

Measurement Validation

CAPA

Regulatory Compliance

Manufacturing Standards

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