Medical Device Quality Engineer III - Catheters

Penumbra, Inc.; Roseville (CA); On-site; USD 98,000 - 137,000; Full time

Benefits offered by this job

Generous benefits package

Equity program

Job summary

Penumbra, Inc. in Alameda, California, is seeking a Quality Engineer III to independently develop and implement quality system elements ensuring high product quality and regulatory compliance.

The role requires collaboration across departments to lead development, testing methodologies, and internal audits, while mentoring junior engineers and adhering to QMS and applicable standards. The position offers a competitive salary and benefits.

Qualifications

• Associate’s or bachelor’s degree in Engineering, Life Sciences, or related field.
• Three+ years of quality engineering experience, preferably in a medical device environment.
• An equivalent combination of education and experience may be considered.
• Familiarity with Quality System Regulations (QSR), ISO standards, and other applicable regulations and laws.

Responsibilities

• Collaborate on and/or help lead development and qualification activities for new and existing products.
• Collaborate on and/or help lead the development of testing and inspection methodologies and documentation for new and existing products.
• Collaborate on and/or help lead Quality Objective teams.
• Design and implement quality control 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 revisions to specifications.
• Partner with other engineering departments, customers, and suppliers to address quality-related issues.
• Collaborate on and/or help lead the development of standard operating procedures.
• Facilitate and perform internal audits.
• Perform responsibilities required by the Quality System and other duties as assigned or requested.
• Provide guidance to junior Quality Engineers and interns in support of departmental functions.
• Adhere to the Company's Quality Management System (QMS), as well as applicable domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy, and compliance principles and adhere to applicable Company regulations, standards, and procedures.
• Ensure that other department members follow the QMS and applicable regulations, standards, and procedures.
• Perform other work-related duties as assigned.
• Indicates an essential function of the role.

Skills

Quality engineering

Verbal communication

Written communication

Leadership

Interpersonal skills

Education

Bachelor’s / Associate degree in Engineering or Life Sciences

Tools

MS Word

MS Excel

MS PowerPoint

Job description

The Quality Engineer III will independently develop and implement appropriate quality system elements to maintain a high level of quality for new and existing products and ensure compliance with applicable regulations and standards.

This role addresses problems of advanced scope where the analysis of situations or data requires a review of identifiable factors. The Quality Engineer III will exercise sound judgment to determine appropriate actions and will communicate and implement quality objectives across the organization.

Specific Duties And Responsibilities

• Collaborate on and/or help lead development and qualification activities for new and existing products.*
• Collaborate on and/or help lead the development of testing and inspection methodologies and documentation for new and existing products.*
• Collaborate on and/or help lead Quality Objective teams.*
• Design and implement quality control 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 revisions to specifications.*
• Partner with other engineering departments, customers, and suppliers to address quality-related issues.*
• Collaborate on and/or help lead the development of standard operating procedures.*
• Facilitate and perform internal audits.*
• Perform responsibilities required by the Quality System and other duties as assigned or requested.*
• Provide guidance to junior Quality Engineers and interns in support of departmental functions.*
• Adhere to the Company's Quality Management System (QMS), as well as applicable domestic and global quality system regulations, standards, and procedures.*
• Understand relevant security, privacy, and compliance principles and adhere to applicable Company regulations, standards, and procedures.*
• Ensure that other department members follow the QMS and applicable regulations, standards, and procedures.*
• Perform other work-related duties as assigned.
• Indicates an essential function of the role.

Position Qualifications

Minimum Education and Experience

• Associate’s or bachelor’s degree in Engineering, Life Sciences, or a related field.
• Three or more years of quality engineering or related experience, preferably in a medical device environment.
• An equivalent combination of education and experience may be considered.

Additional Qualifications

• Familiarity with Quality System Regulations (QSR), ISO standards, and other applicable regulations and laws.
• Excellent verbal, written, and interpersonal communication skills.
• Demonstrated or developing leadership skills preferred.
• Proficiency with Microsoft Word, Excel, and PowerPoint.

Annual Base Salary Range: $98,000 to $137,000

We offer a competitive compensation package, along with benefits and an equity program when applicable.

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

Working Conditions

• Work is performed in general office, laboratory, and cleanroom environments.
• Business travel may range from 0% to 10%.
• May occasionally be required to lift and move items weighing up to 25 pounds.
• Must be able to move between buildings and floors.
• Must be able to remain stationary and use a computer and other standard office equipment, such as printers and copy machines, for extended periods each day.
• Must be able to read and prepare emails, documents, and spreadsheets.
• Must be able to move throughout the office and access file cabinets and supplies as needed.
• Must be able to communicate and exchange accurate information with employees at all organizational 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.