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Full-Time

Manufacturing Engineer III

Confirmed live in the last 24 hours

Penumbra Inc

Penumbra Inc

1,001-5,000 employees

Develops medical devices for vascular conditions

Hardware
Biotechnology
Healthcare

Compensation Overview

$98.8k - $131.3kAnnually

Junior, Mid

Roseville, CA, USA

Category
Manufacturing Engineering
Mechanical Engineering
Required Skills
Communications
Requirements
  • Bachelor's degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering or related degree with 2+ years relevant engineering experience, or an equivalent combination of education and experience
  • Engineering experience in a manufacturing environment recommended, medical device industry preferred
  • Excellent written, verbal, and interpersonal communication skills required; leadership skills desired
  • 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
Responsibilities
  • Solve complex problems and implement innovative solutions.
  • Execute detailed root cause analysis and recommend vetted solutions.
  • Communicate and explain problems and solutions cross functionally and interdepartmentally.
  • Approach problems from a detail-oriented perspective.
  • Suggest independent recommendations for project approach, scope, and tactics.
  • Support production; Creating and maintaining product and process documentation; Monitor process and equipment performance and identify and implement process improvement activities to increase/optimize yield, efficiency, and/or throughput.
  • 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.
  • Design fixtures, acquire off-the-shelf tooling and equipment, and implement new fixturing on the production line. Perform equipment qualifications.
  • Test processes, equipment, raw materials, and product. Perform process validations. Author protocols to execute tests, write reports, and make conclusions and/or recommendations based on test results
  • Plan, schedule, conduct, and coordinate detailed phases of engineering work as part of a project or as a total project.
  • Develop specifications of a product, process, or piece of equipment
  • Develop, characterize, and optimize processes using statistical techniques and engineering knowledge and experience
  • Coordinate with the appropriate suppliers and other external resources needed in developing and implementing process improvement plans
  • Participate in project planning and scheduling
  • Train assemblers, quality control and technicians, as necessary, on processes, equipment, and documentation
  • Perform other activities requiring knowledge of principles and techniques commonly employed in the specific area of projects. 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.

Penumbra Inc. specializes in creating medical devices aimed at treating neurovascular and peripheral vascular conditions. Their products, such as the Penumbra System and the Indigo System, are designed to assist healthcare professionals in addressing issues like stroke and other vascular diseases. These devices work by providing advanced tools for interventions in neurology and vascular surgery, allowing for effective treatment options. Unlike many competitors, Penumbra focuses on a specific range of conditions and invests heavily in research and development to continuously enhance their offerings. The company's goal is to deliver high-quality medical devices that meet the needs of healthcare providers and improve patient outcomes.

Company Stage

IPO

Total Funding

$3.4M

Headquarters

Alameda, California

Founded

2004

Growth & Insights
Headcount

6 month growth

4%

1 year growth

8%

2 year growth

17%
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Simplify's Take

What believers are saying

  • Penumbra's recent product launches, such as the BMX81 and BMX96 in Europe, demonstrate their commitment to expanding and improving their product portfolio.
  • Significant investments from firms like Jennison Associates LLC and Algert Global LLC indicate strong financial backing and confidence in Penumbra's growth potential.
  • The company's participation in high-profile conferences like the Truist Securities MedTech Conference and the William Blair Growth Stock Conference highlights its industry recognition and thought leadership.

What critics are saying

  • The highly competitive medical device market requires Penumbra to continuously innovate to maintain its market position.
  • Regulatory challenges and the need for CE Marks and FDA approvals can delay product launches and impact revenue.

What makes Penumbra Inc unique

  • Penumbra's focus on both neurovascular and peripheral vascular conditions sets it apart from competitors who may specialize in only one area.
  • Their continuous investment in R&D ensures that they remain at the forefront of medical device innovation, particularly with recent launches like the Lightning Flash 2.0 CAVT technology.
  • Penumbra's global reach, serving healthcare providers in over 100 countries, provides a broad market presence that many competitors lack.