Penumbrainc Development Quality Engineer I at Penumbrainc supports product development teams to design and qualify new medical device products. Develops and implements quality system elements ensuring compliance with regulations and standards.
Responsibilities
Participate in the 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. *
Qualification
Familiarity with QSRExcellent verbalProficiency with MS WordAlamedaAnnual Base Salary RangeGeneral officeMust be able to readLocation and Pay
Required
Associate’s or Bachelor's degree in Engineering, a Life Science or a related field, plus quality engineering or relevant experience, preferably in a medical device environment, or equivalent combination of education and experience
Familiarity with QSR, ISO and other applicable regulations and laws required
Excellent verbal, written, and interpersonal communication skills
Proficiency with MS Word, Excel, and PowerPoint
Alameda, CA
Annual Base Salary Range: $80,000 to $105,000
General office, laboratory, and cleanroom environments
Potential exposure to blood-borne pathogens
Requires some lifting and moving of up to 25 pounds
Must be able to move between buildings and floors.
Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
Must be able to read, prepare emails, and produce documents and spreadsheets.