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In a pivotal role on our quality engineering team, you will be the driving force behind the quality of some of Penumbra's most innovative products. You will provide leadership and drive results in all aspects of product 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. Your efforts will directly impact the safety of patients around the world who use Penumbra's products. You will apply your passion for detailed analysis for identifying problems and determining the appropriate course of action. You will be looked to for communicating quality objectives and building a culture of quality throughout the company.
What Success Looks Like
As a leader, manage the quality engineering functions in support of production to ensure conformance to the Penumbra Quality Management System, FDA QSR, ISO standards, and other regulatory requirements within a multidisciplinary team.
Direct management of Quality Engineers that support quality inspection and manufacturing of Penumbra products.
Mentor and develop cross-functional team members with the mentality that their success is your success.
Provide subject matter expertise with external/internal audits, design of experiments, process validations, statistics, test method development/validations, measurement system analysis, sterilization validations, new product development/introduction, and risk management.
Take the lead on continuous improvement initiatives and other activities to ensure company and operational goals are met.
With your top-notch critical thinking, find ways to make Penumbra's quality system better.
Ensure product quality associated with our most robust array of product lines.
With a high level of customer service, provide engineering support to designated production lines.
Support the vendor management process to maintain strong relationships with suppliers.
Continually improve technical processes and ensure reliability; implement inspections that meet Penumbra's quality standards.
Manage the Key Performance Indicators (KPIs) for assigned product families and functional production areas.
Assess, develop, evaluate, implement, and maintain process control systems.
What You Bring
Bachelor's degree required (biomedical, mechanical, chemical or materials engineering preferred).
Class III (preferred) or Class II medical device experience required.
Proven track record of working with applicable regulations and standards, e.g. QSR, ISO 13485 required.
5+ years of industry experience required.
1+ years of leadership experience required; people management experience preferred.
Proven work history of growing within an organization, learning its systems, and showing initiative preferred.
The ability to present issues, plans, and objectives in a clear, compelling way, both verbally and through documentation preferred.
Previous manufacturing engineering or process development experience preferred.
Direct manufacturing/operation support experience preferred.
NPI quality engineering experience preferred.
Lean Six Sigma experience nice to have, but not required.
Sterilization and biocompatibility experience nice to have, but not required.
Versatility, flexibility, and willingness to work within a dynamic environment.
Working knowledge of data collection, data analysis/evaluation, and scientific methodology.
Working Conditions
General office environment. Business travel from 0% - 10%. Potential exposure to blood-borne pathogens. Requires some lifting and moving of up to 25 pounds. The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.
Location: Alameda, CA
Starting Base Salary is $151,290/year - $213,560/year.
Individual compensation will vary over time based on factors such as performance, skill level, competencies, work location and shift.
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).
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