Medical Device Quality Engineer II — PCB QC & Compliance

Penumbra, Inc.; San Francisco (CA); On-site; USD 95,000 - 127,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401(k) with employer match

Paid parental leave

Paid holidays and vacation

Disability insurance

Life insurance

Job summary

Penumbra, Inc. is seeking a Quality Engineer II to develop and implement quality system elements ensuring high product quality and regulatory compliance.

You will work with issues of moderate scope, analyze data, and communicate quality objectives across teams. Responsibilities include collaborating on development and qualification of products, maintaining PCB issue tracking, designing QC sampling and inspection methods, performing failure analyses, and driving internal audits under the QMS.

Qualifications

• Associate’s or Bachelor's degree in Engineering or Life Science plus 2+ years of quality engineering experience.
• Familiarity with QSR, ISO and other regulations; IEC 60601.
• Experience with electronics devices/PCBAs and manufacturing environments.
• Strong communication and documentation skills; proficient in MS Office.

Responsibilities

• Collaborate in development and qualification activities for new and existing products.
• Maintain and track hardware PCB issues and communicate findings to stakeholders.
• Collaborate in the development of testing and inspection methodology and documentation for new and existing products.
• Design and install QC process sampling systems, procedures, and statistical techniques.
• Design or specify inspection and testing mechanisms and equipment.
• Perform failure analyses and defect investigations.
• Analyze production limitations and standards.
• Interface with other engineering departments within the company, customers, and suppliers on quality related issues.
• Collaborate in the development of standard operating procedures.
• Facilitate and perform internal audits.
• 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 applicable regulations and procedures.
• Ensure other department members follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned.

Skills

Quality engineering

Communication

Team collaboration

Education

Bachelor's or Associate degree in Engineering or Life Science

Tools

MS Word

Excel

PowerPoint

Job description

Penumbra, Inc. is seeking a Quality Engineer II to develop and implement quality system elements ensuring high product quality and regulatory compliance.

You will work with issues of moderate scope, analyze data, and communicate quality objectives across teams. Responsibilities include collaborating on development and qualification of products, maintaining PCB issue tracking, designing QC sampling and inspection methods, performing failure analyses, and driving internal audits under the QMS.