Medical Device Quality Engineer II

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

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with employer match

Paid parental leave

Eleven paid company holidays

Accrued vacation (15+ days)

Job summary

Penumbra, Inc. is seeking a Quality Engineer II to develop and implement quality system elements ensuring high-quality medical devices conform to regulatory standards.

You will analyze problems of moderate scope, exercise judgment, and communicate quality objectives across teams. Responsibilities include collaboration on product qualification, PCB issue tracking, QA testing methodology, QC sampling, and internal audits.

Qualifications

• Associate’s or Bachelor's degree in Engineering, a Life Science, or a related field, with 2+ years of quality engineering or relevant experience, preferably in a medical devices or regulated industry environment, or equivalent combination of education and experience.
• Familiarity with QSR, ISO and other applicable regulations and laws required
• Familiarity with IEC 60601
• Engineering experience in a manufacturing environment recommended, medical device industry preferred
• Experience with Electronic devices and or PCBAs
• Excellent verbal, written, and interpersonal communication skills
• Proficiency with MS Word, Excel, and PowerPoint

Responsibilities

• Collaborate in the development and qualification activities for new and existing products
• Maintain and track critical hardware PCB issues, document findings, and ensure effective communication with relevant 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
• Recommend revision of specifications
• 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 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

Communication skills

MS Word, Excel, PowerPoint

Education

Engineering degree or related field

Job description

The Quality Engineer II professional develops and implements appropriate quality system elements to ensure the high-quality level of new and existing products as well as their compliance with applicable regulations and standards. Work with problems of moderate scope where the analysis of the situation or data requires a review of identifiable factors. Exercise judgment to determine appropriate action. Communicate and implement quality objectives.

Specific Duties and Responsibilities

• Collaborate in the development and qualification activities for new and existing products*
• Maintain and track critical hardware PCB issues, document findings, and ensure effective communication with relevant 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 *
• Recommend revision of specifications *
• 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 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

*Indicates an essential function of the role

Location and Salary:

• Annual Base Salary: $95,000 to $127,000

We offer a competitive compensation package plus a benefits and equity program, when applicable.

Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

Position Qualifications

• Associate’s or Bachelor's degree in Engineering, a Life Science, or a related field, with 2+ years of quality engineering or relevant experience, preferably in a medical devices or regulated industry environment, or equivalent combination of education and experience.
• Familiarity with QSR, ISO and other applicable regulations and laws required
• Familiarity with IEC 60601
• Engineering experience in a manufacturing environment recommended, medical device industry preferred
• Experience with Electronic devices and or PCBAs
• Excellent verbal, written, and interpersonal communication skills
• Proficiency with MS Word, Excel, and PowerPoint

Working Conditions

• 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.
• Must be able to move within the office and access file cabinets or supplies, as needed.
• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

What We Offer

• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.

If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.

For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.