Sr. Quality Engineer

General Summary

As a Senior Quality Engineer at Penumbra, you will participate in all aspects of process development, supplier development and manufacturing in order to ensure the highest level of quality in new and existing products, and their compliance to applicable regulations and standards. You will apply your passion for detailed analysis to identify problems and determine the appropriate course of action. You will be looked to for communicating quality objectives and building a culture of quality throughout the company.

What You’ll Work On

• Represent Quality Engineering on cross-functional teams - interfacing among multiple departments and teams such as Manufacturing, QC, R&D, Regulatory Affairs, Operations/Planning, and Marketing.

• Evaluate, analyze, and continuously improve manufacturing processes, quality controls, and engineering systems for assigned product lines.

• Own or review Engineering Change Orders on assigned projects and product lines.

• Plan, design, and implement test/inspection methods, including test/inspection equipment, to achieve product quality control objectives.

• Partner with suppliers to continually improve technical processes, reliability, and quality controls to meet Penumbra's quality standards.

• Take the lead on risk analysis and documentation.

• Lead or participate in project teams - coordinating the quality efforts to meet project objectives.

• Plan, schedule, and execute engineering project work to meet business and quality objectives.

• Provide leadership and guidance to ensure assigned projects and product lines are compliant with the quality system and regulations.

• Lead nonconforming report investigations and recommend appropriate corrective actions.

• Identify the need for Corrective Action Preventative Action (CAPA). Initiate, implement, and close CAPAs.

• Design experiments and tests, and apply statistical rationale to analyze, and interpret engineering test data.

• Provide leadership and mentoring to more junior staff. May supervise junior engineers.

Position Qualifications

Minimum education and experience:

• Bachelor’s degree in Engineering, a Life Science or related field with 5+ years or relevant experience, including experience in Quality Assurance and ISO, or an equivalent combination of education and experience

Additional qualifications:

• Advanced degree preferred

• Experience in auditing, design review, sterilization, project management, and/or product development is highly desired

What You'll Bring

• A passion for detailed analysis and problem solving.

• A knack for solving quality control problems effectively.

• The desire to be part of a great team and to represent Quality Engineering on cross-functional technical teams.

• The ability to present issues, plans, and objectives in a clear, compelling way, both orally and in writing.

• Versatility, flexibility, and a willingness to work within changing priorities.

• Broad knowledge of applicable regulations and standards, e.g. QSR, ISO 13485.

• Solid knowledge of sterilization, biocompatibility, and transportation and shelf-life standards

• Working knowledge of data collection, data analysis, and evaluation, and scientific methods.

• R&D or new product development experience helpful.

• ASQ CQE preferred.

Working Conditions

• General office, laboratory, and cleanroom environments.

• Business travel from 0% - 10%.

• 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, an employee stock purchase plan, 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).