Junior Development Quality Engineer - Medical Devices

Penumbrainc; Alameda (CA); On-site; USD 80,000 - 105,000; Full time

Benefits offered by this job

Medical benefits

401(k) with employer match

Paid time off & holidays

Job summary

Penumbra, Inc. in Alameda, CA is seeking a Development Quality Engineer I to partner with product teams in designing and qualifying life-saving devices.

You will implement quality system elements to ensure regulatory compliance and high product quality, helping get innovative therapies to market safely and efficiently. The role covers development support, testing methodology, design controls, and cooperation with suppliers and customers while upholding the company’s QMS and privacy and security

Qualifications

• Associate or bachelor’s degree in engineering or life sciences with quality engineering experience.
• Medical device environment experience preferred.
• Excellent communication and interpersonal skills.

Responsibilities

• Participate in product development and qualification activities for new and existing products.
• Participate in Product Development teams.
• Develop testing, inspection methodology, and documentation for new and existing products.
• Design and install quality sampling systems and procedures utilizing statistical analysis.
• Design or specify inspection and testing equipment to meet product requirements.
• Perform failure analyses and defect investigations.
• Analyze and apply design control standards.
• Recommend revision of specifications, procedures, and work instructions for device design and process improvement.
• Interface with other internal departments, customers, and suppliers on product and quality-related issues.
• 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 engineering

MS Word

Excel

PowerPoint

Communication skills

Team collaboration

Education

Associate's or Bachelor's degree in Engineering or Life Science

Job description

Penumbra, Inc. in Alameda, CA is seeking a Development Quality Engineer I to partner with product teams in designing and qualifying life-saving devices.

You will implement quality system elements to ensure regulatory compliance and high product quality, helping get innovative therapies to market safely and efficiently. The role covers development support, testing methodology, design controls, and cooperation with suppliers and customers while upholding the company’s QMS and privacy and security