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Quality Engineer I - Electronics

General Summary 

You will have an opportunity to identify and own high impact projects for life saving medical devices. In this opportunity, you will independently support new and existing products to ensure the high-quality development and manufacturing of interventional medical devices. This position will provide work with problems of moderate scope under guidance where the analysis of situation or data requires a review of identifiable factors. Work with collaborative teams to exercise good judgment to determine appropriate quality actions, and communicate and implement quality objectives.


Specific Duties and Responsibilities 

•Participate in the development and qualification activities for new and existing products* 

•Develop testing and inspection methodology and documentation for new and existing products* 

•Participate on Quality Objective teams* 

•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* 

•Work in compliance of standard operating procedures* 

•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: 

Location: Alameda, CA 

Salary: $80,000 to $105,000


Position Qualifications 

Minimum education and experience: 

•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 devices’ environment, or equivalent combination of education and experience


Additional qualifications:   

•Familiarity with QSR, ISO and other applicable regulations and laws required 

•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, 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).

 

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.

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Average salary estimate

$92500 / YEARLY (est.)
min
max
$80000K
$105000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Quality Engineer I - Electronics, Penumbra

At Penumbra, Inc., located in the sunny city of Alameda, CA, we’re on the lookout for a passionate Quality Engineer I - Electronics to join our dynamic team! This isn’t just any job; it's your chance to make a real difference in the world of life-saving medical devices. In this role, you’ll be diving into exciting projects that help improve patient outcomes. You'll work closely with new and existing products, ensuring they meet the highest quality standards throughout their development and manufacturing processes. Your analytical skills will come into play as you help design testing methodologies, troubleshoot failures, and implement strategic quality objectives. Collaborating with your fellow engineers and quality teams, you’ll be instrumental in adhering to our Quality Management System (QMS) and related regulations. And don’t worry; you won’t be in this alone! We believe in fostering a supportive and collaborative environment where ideas flow freely, and your skills will be utilized to their fullest. With a salary range between $80,000 and $105,000, plus a fantastic benefits package, this role not only opens the door to professional growth but also empowers you to contribute to groundbreaking innovations. If you’re ready to step up and take on the challenge as a Quality Engineer I - Electronics, we’d love to hear from you!

Frequently Asked Questions (FAQs) for Quality Engineer I - Electronics Role at Penumbra
What are the main responsibilities of a Quality Engineer I - Electronics at Penumbra?

As a Quality Engineer I - Electronics at Penumbra, your primary responsibilities will include supporting the development and qualification of new and existing medical devices. You’ll participate in designing and implementing quality control processes and inspection techniques, perform failure analyses, and ensure compliance with standard operating procedures and relevant quality regulations. Engaging with collaborative teams, you'll help maintain and elevate the quality standards essential for life-saving products.

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What qualifications do I need to be a Quality Engineer I - Electronics at Penumbra?

To become a Quality Engineer I - Electronics at Penumbra, you will need an Associate’s or Bachelor's degree in Engineering, Life Sciences, or a related field. Relevant experience in quality engineering, especially within the medical device industry, is preferred. Familiarity with regulations such as QSR and ISO is essential, alongside strong communication skills and proficiency in tools like MS Word and Excel.

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What kind of work environment can I expect as a Quality Engineer I - Electronics at Penumbra?

In the role of Quality Engineer I - Electronics at Penumbra, you can expect a mix of working in an office environment, laboratories, and cleanrooms. You may occasionally come into contact with sensitive materials, and the position requires you to be adaptable to moving between locations within the facility. The work is dynamic and encourages a proactive approach to ensuring product quality.

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How does Penumbra support professional development for Quality Engineer I - Electronics?

Penumbra emphasizes a collaborative learning environment, offering numerous opportunities for professional development for Quality Engineer I - Electronics. This includes ongoing training, mentorship from experienced team members, and exposure to innovative projects that drive personal growth along with the company's mission to tackle significant medical challenges.

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What is the salary range for a Quality Engineer I - Electronics at Penumbra?

The salary range for a Quality Engineer I - Electronics at Penumbra is between $80,000 and $105,000. Along with a competitive salary, the position comes with a comprehensive benefits package, which includes medical, dental, vision, life insurance, a 401(k) plan with employer match, paid vacation time, and more, ensuring our employees are well taken care of.

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Common Interview Questions for Quality Engineer I - Electronics
Can you describe your experience with quality control processes in a manufacturing environment?

When answering this question, it's important to highlight specific examples from your previous roles. Discuss the methodologies you implemented, how you monitored compliance with standards, and any successes you achieved in improving product quality. Mention your familiarity with QSR and ISO as they relate to your experience.

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How do you approach failure analysis and defect investigation?

For this question, emphasize your systematic approach to failure analysis. Describe a situation where you successfully identified the root cause of a defect, the tools or techniques you used, and the corrective actions taken. It’s crucial to showcase your analytical skills and your ability to collaborate with cross-functional teams.

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What testing methodologies do you believe are most effective for medical device quality assurance?

Discuss a variety of testing methodologies you have experience with, such as statistical sampling techniques, inspection standards, and risk assessments. Tailor your response to include examples relevant to medical device testing, reflecting on how these approaches help ensure product safety and efficacy.

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How do you ensure compliance with quality regulations and standards?

In your response, outline your knowledge of specific regulations such as QSR, ISO, and relevant standards. Talk about your experience in auditing processes, maintaining documentation, and how you stay updated on regulatory changes to ensure ongoing compliance.

Join Rise to see the full answer
Describe a time when you had to work with a cross-functional team to achieve a quality objective.

Share a specific example that highlights your teamwork and communication skills. Explain your role in the project, how you facilitated collaboration among diverse team members, and the successful outcome achieved through effective teamwork.

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What tools and software do you use for quality management?

Be sure to mention any quality management systems (QMS) you have used in your prior roles. Discussing familiarity with software like MS Excel for data analysis, and other project management tools will show your technical proficiency. If applicable, share results obtained through the effective use of these tools.

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How do you handle tight deadlines without compromising on quality?

Demonstrate your time management and prioritization skills. Discuss strategies you employ to maintain quality even when under pressure, such as setting clear objectives, focusing on critical tasks, and collaborating with team members to allocate responsibilities.

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What do you believe is the role of a Quality Engineer in a medical device company?

Explain that the role of a Quality Engineer is crucial in ensuring that medical devices are safe and effective. Mention responsibilities such as ensuring compliance with quality regulations, participating in the development and testing phases, and being the bridge between engineering and regulatory requirements.

Join Rise to see the full answer
How do you prioritize tasks in your workflow as a Quality Engineer?

Discuss how you evaluate urgency and importance when prioritizing tasks. Provide insights into how you maintain a balance between routine quality checks and addressing urgent quality issues, illustrating your problem-solving skills.

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What motivates you to work in quality engineering within the medical device industry?

Reflect on your passion for contributing to life-saving innovations and the impact associated with the medical device industry. Emphasize your commitment to quality and how it plays a significant role in ensuring positive patient outcomes.

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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 ...

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DATE POSTED
April 6, 2025

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