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Manufacturing Engineer II, Operations

General Summary

The mission of the Manufacturing Engineering group is to provide manufacturing technology and robust solutions that commercialize new products and that support continuous improvement in production. Project opportunities are designed to develop professional work knowledge and abilities and to support the efforts and projects that have global importance to the success of the business. Area of work involves manufacturing and business processes with interaction between production, cross-departmental engineering groups, and other cross-functional teams (such as Regulatory, Quality, R&D, Supply Chain, IT, etc.) in executing and coordinating business operations systems projects and activities. Essential job functions include creating and executing an integrated cross-functional project plan.

 

Specific Duties and Responsibilities

As assigned by a project team leader or a manager, as self-identified, or as business needs dictate, independently perform any of the following:

• Solve complex problems and implement innovative solutions. *

• Execute detailed root cause analysis and recommend vetted solutions. *

• Effectively and succinctly communicate task or activity status, assumptions, risks, timeline, and escalations cross-functionally and interdepartmentally, as required. *

• Facilitate cross-functional coordination to implement changes and improvements to operational systems and processes, with knowledge and consideration towards requirements and inputs from cross-functional teams and key stakeholders. *Coordinate project risk management to successful completion of tasks and activities, appropriately escalating issues to management or leadership, as required. *

• Approach problems from a detail-oriented perspective. *

• Suggest independent recommendations for project approach, scope, and tactics. *

• Demonstrate an understanding of quality, operational, and financial systems, company products and customer requirements and how the product or project impacts the objectives of the business. Demonstrate an understanding of how other functional groups within the company are impacted by projects at hand and can impact the project or product results.

• Plan, schedule, conduct, and coordinate detailed phases of engineering work as part of a project or as a total project. *

• Coordinate with the appropriate suppliers and other external resources needed in developing and implementing process improvement plans. *

• Participate in project planning and scheduling. *

• 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

 

Position Qualifications

Minimum education and experience:

• Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering or related degree, and 1+ years relevant engineering experience, or an equivalent combination of education and experience

 

Additional qualifications:

• Engineering experience in a manufacturing environment recommended, medical device industry preferred

• Excellent written, verbal and interpersonal communication skills required

• Knowledge of FDA regulations, Lean/Flow Manufacturing, and/or materials and manufacturing processes desired

• Proficiency in Word, Excel, PowerPoint, Access, and other computer applications required

• High degree of accuracy and attention to detail

• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously

 

Location and Salary

• Alameda, CA ($98,000 to $128,000)

• Roseville, CA ($88,000 to $115,000)

 

Working Conditions

• General office, laboratory, and cleanroom environments

• 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.

 

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

$108000 / YEARLY (est.)
min
max
$88000K
$128000K

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 Manufacturing Engineer II, Operations, Penumbra

Are you ready to make a real impact in the healthcare industry? Penumbra, a pioneering company focused on innovative therapies, is looking for a Manufacturing Engineer II to join our Operations team. In this role, you'll have the opportunity to work collaboratively with cross-functional teams, including Quality, R&D, and Supply Chain, to implement manufacturing technology that supports continuous improvement and the commercialization of new products. You'll dive deep into complex problem-solving, use your analytical skills to conduct root cause analyses, and communicate effectively across departments to keep everyone aligned. As a Manufacturing Engineer II, your day-to-day will involve planning and coordinating projects aimed at enhancing operational systems, while also considering various stakeholder input in the process. Whether you’re improving engineering workflows or engaging with suppliers for process enhancement, your contributions are vital to our global success. With a Bachelor’s degree in Engineering and relevant experience under your belt, this role offers the chance to develop professional knowledge in a fast-paced environment where every day presents new challenges and opportunities. Plus, we offer a generous benefits package, including healthcare, 401(k) matching, and paid vacation. Join us at Penumbra and be part of a team that's changing the future of healthcare, one innovation at a time!

Frequently Asked Questions (FAQs) for Manufacturing Engineer II, Operations Role at Penumbra
What are the responsibilities of a Manufacturing Engineer II at Penumbra?

The Manufacturing Engineer II at Penumbra is responsible for executing complex problem-solving strategies, conducting detailed root cause analyses, facilitating cross-functional teams, and managing project risk while ensuring compliance with quality management standards. This role involves a significant amount of communication with various departments to coordinate project implementations and monitor progress, making it essential for the engineer to have excellent interpersonal skills.

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What qualifications are required for the Manufacturing Engineer II position at Penumbra?

To qualify for the Manufacturing Engineer II role at Penumbra, candidates must possess a Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering, along with at least one year of relevant engineering experience. Experience in a manufacturing environment, preferably in the medical device industry, is highly recommended. Additionally, strong communication skills and familiarity with FDA regulations and Lean Manufacturing principles are beneficial.

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What kind of projects will I work on as a Manufacturing Engineer II at Penumbra?

In the Manufacturing Engineer II role at Penumbra, you will engage in projects that focus on improving production processes, coordinating engineering phases, and implementing process improvements based on cross-functional collaboration. You’ll participate in projects that aim to enhance operational efficiency and support the creation of innovative medical products that address significant health challenges.

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What is the work environment like for a Manufacturing Engineer II at Penumbra?

The work environment for a Manufacturing Engineer II at Penumbra includes a mix of general office settings, labs, and cleanrooms. You may also encounter some exposure to biological hazards, necessitating adherence to strict safety protocols. The position requires the ability to sit for extended periods, use a computer, and occasionally lift objects up to 25 pounds.

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What benefits does Penumbra offer to its Manufacturing Engineer II employees?

Penumbra offers an attractive benefits package for its Manufacturing Engineer II employees, which includes medical, dental, and vision coverage, life insurance, paid holidays, vacation time that increases with tenure, a 401(k) plan with employer matching, and employee stock purchase options. The supportive environment enhances work-life balance, making it an excellent place to grow your career.

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Common Interview Questions for Manufacturing Engineer II, Operations
What experience do you have that prepares you for the Manufacturing Engineer II role at Penumbra?

When answering this question, share specific examples of your engineering experience, particularly in manufacturing or a related field. Highlight any projects where you solved complex problems, conducted analyses, or worked with cross-functional teams. Tailoring your answer to demonstrate how your skills align with Penumbra's mission will show your suitability for the role.

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How do you approach problem-solving as a Manufacturing Engineer?

Discuss your methodical approach to problem-solving, including identifying the issue, performing root cause analysis, and developing innovative solutions. Use instances from your past experiences to illustrate your analytical thinking and effectiveness in implementing changes that improved processes.

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Can you give an example of a successful cross-functional project you managed?

Share a specific instance where you led a cross-functional project, detailing your role in facilitating communication between various teams. Emphasize the impact of your contributions on project success and any metrics that demonstrate the achievement of objectives.

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How do you ensure compliance with quality management systems?

Explain your familiarity with quality management systems, such as QMS and FDA regulations, and describe how you incorporate compliance into your daily work. Provide an example of a time you ensured adherence to these standards and the steps you took to monitor compliance effectively.

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What strategies do you use to prioritize tasks in a project?

Discuss your time management strategies, such as utilizing project management tools or methodologies like Lean. Illustrate how you assess project demands and deadlines to prioritize tasks, ensuring that critical deadlines are met without compromising quality.

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What role does communication play in your engineering projects?

Describe the importance of clear and effective communication in your engineering projects, especially in collaborative efforts. Provide examples of how you’ve facilitated discussions or resolved conflicts between teams to keep projects on track and stakeholders informed.

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How do you handle project risk management?

Highlight your understanding of risk management processes, including identifying, assessing, and mitigating risks associated with projects. Use an example to show how you’ve successfully managed risks in a previous project and escalated issues appropriately.

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What computer applications do you use to support your engineering tasks?

Mention the various software tools you are proficient in, such as Word, Excel, PowerPoint, and project management systems. Discuss how you leverage these applications to optimize your workflow, manage data, and analyze project results.

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Describe a situation where you had to adapt to changes in project scope or objectives.

Provide an example where you had to be flexible due to changing project requirements. Explain how you adapted your approach while keeping the project aligned with the overall goals, demonstrating your resilience and problem-solving skills.

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What do you know about Penumbra and its impact on the healthcare industry?

Research and understand Penumbra's mission, values, and its role in developing innovative therapies. Share your knowledge of its products and their significance in addressing challenging medical conditions, showcasing your enthusiasm for the company and the Manufacturing Engineer II position.

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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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Full-time, on-site
DATE POSTED
December 10, 2024

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