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

Key technologies and capabilities for this role

Quality AssuranceDesign ControlStatistical AnalysisProduct QualificationInspection MethodsTesting ProceduresMeasurement ValidationCAPARegulatory ComplianceManufacturing Standards

Questions & Answers

Common questions about this position

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

This information is not specified in the job description.

What is the salary or compensation for the Senior Quality Engineer role?

This information is not specified in the job description.

What key skills and responsibilities are required for this role?

The role requires skills in developing quality standards for manufacturing, monitoring design control, performing statistical analysis, supporting FDA inspections, and leading project teams in quality efforts for product development.

What does the team structure look like for this position?

The role involves selecting, managing, training, and developing staff, establishing objectives, assignments, and providing ongoing feedback through performance reviews and development plans.

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

A strong candidate is a fully qualified engineer capable of independent evaluation, devising new approaches to complex problems, leading quality efforts in product development, and adhering to the company's Quality Management System and regulations.

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