Penumbra Inc

Neurovascular and peripheral medical devices manufacturer

Senior Manufacturing Engineer

Manufacturing EngineeringConfirmed live in the last 24 hours

Full-timeRoseville, CA, USA

About the Job

Requirements

A bachelor's degree in engineering or a related technical field, with 4 or more years of engineering-level experience, preferably in the medical device industry, or an equivalent combination of education and experience.
Detailed knowledge of Good Manufacturing Practices (GMP), Quality System Regulations, and clean room environment practices.
Demonstrated knowledge of engineering and scientific principles.
High proficiency with computers and software applications.
Willingness and ability to work on site.
Ability to travel for business from 0% to 10%.
Ability to lift and move up to 25 pounds.
Ability to remain stationary and use a computer or other standard office equipment for an extensive period each day.
Ability to read, prepare emails, and produce documents and spreadsheets.
Ability to move within the office and access file cabinets or supplies as needed.

Responsibilities

Provide leadership in engineering, design, and development of new products or changes to existing products, processes, and equipment.
Interface with multidisciplinary teams overseeing development of neurovascular devices and furnish scientific knowledge to those teams.
Provide engineering support on existing devices for manufacturing.
Develop, configure, and troubleshoot processing and test equipment.
Research, identify, and evaluate automated processing equipment.
Specify fixtures and tooling to support automated equipment.
Navigate quality management systems within scope and maintain general knowledge of quality systems beyond scope.
Develop new processes for medical devices and components.
Execute tasks independently, recommend vetted solutions, and think strategically within scope.
Create drawings for Production and Research and Development.
Manage projects as a Project Leader within a multidisciplinary team of peers, lead other engineers independently, and influence other departments with guidance.
Provide technical support and perform tasks within multidisciplinary project teams.
Document manufacturing and production development processes through lab notebooks, engineering protocols, and engineering reports.
Identify and utilize vendors in the development of processes for company products.
Perform research and integrate new technologies into existing and future products and processes.
Train engineers, technicians, and assemblers in new processes and methods.
Evaluate and troubleshoot problems to assess root cause and corrective action.
Interpret and communicate test results, solve practical problems, and document findings and recommendations.
Create and modify product design specifications.
If in a supervisory position, select, manage, train, and develop staff; establish objectives and assignments; and provide ongoing feedback through performance reviews and development plans.
Adhere to the company's Quality Management System and applicable domestic and global quality system regulations, standards, and procedures.
Understand and adhere to applicable security, privacy, and compliance principles, regulations, standards, and procedures.
Ensure other department members follow the Quality Management System and applicable regulations, standards, and procedures.
Perform other work-related duties as assigned.

Desired Qualifications

A master's degree.
Experience in the medical device industry.

General Summary

The Sr Manufacturing Engineer provides leadership in the engineering, design and development of new products or changes to existing products, processes, and equipment. Interfaces with and furnishes scientific knowledge to multi-disciplinary teams overseeing development of neurovascular devices. Provide engineering support on existing devices for manufacturing. Develop, configure, and troubleshoot processing and test equipment. Research, identify and evaluate automated processing equipment. Specify fixtures/tooling for automated equipment support.

Specific Duties and Responsibilities

• Fluently navigate quality management systems within scope and have general knowledge of quality systems beyond scope. * • Develop new processes for medical devices and components *

• Execute tasks independently and does not require assistance nor guidance. Recommends vetted solutions independently. *

• Thinks strategically within scope. *

• Create drawings for Production and Research and Development *

• Manage projects as a Project Leader within a multidisciplinary project team of peers independently. Leads other engineers independently. Influences other departments with guidance. *

• Provide technical support and perform tasks within multidisciplinary project team *

• Document manufacturing and production development process through lab notebooks, engineering protocols, and engineering reports *

• Identify and utilize vendors in the development of processes for Penumbra, Inc. products *

• Perform research and integrate new technologies into existing and future products and processes *

• Train engineers, technicians and assemblers in new processes and methods *

• Evaluate and troubleshoot problems to assess root cause and corrective action *

• Interpret and communicate test results *

• Solve practical problems encountered *

• Document findings and recommendations *

• Create and modify product design specifications *

• If in a supervisory position, select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans. *

• 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 engineering or related technical field with 4+ years of engineering level experience, preferably in the medical device industry, or an equivalent combination of education and experience

Additional qualifications:

• Master’s degree preferred

• Detailed knowledge of GMP/Quality System Regulations and clean room environment practices

• Demonstrated knowledge of engineering and scientific principles

• High proficiency with computers and software applications

Working Conditions

• General office, laboratory, and clean room environments.

• Willingness and ability to work on site.

• 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 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.

Annual Base Salary Range: $113,000 - $157,000

We offer a competitive compensation package plus a benefits and equity program, when applicable.

Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

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, 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 seePenumbra's AAP Policy Statement.

About the Company

Penumbra Inc

Neurovascular and peripheral medical devices manufacturer

Penumbra Inc. designs, develops, and sells medical devices for neurovascular and peripheral vascular conditions. Its products are used by doctors in hospitals and clinics and work by being inserted into blood vessels to remove clots, support catheter-based procedures, or help reconstruct vessels. The company differentiates itself with a broad, integrated portfolio across neurovascular and peripheral interventions and a global sales network that serves Europe and the Americas. Its goal is to improve patient outcomes through high-quality tools and ongoing research and development to expand capabilities.

Company size: 1,001-5,000
Company stage: IPO
Headquarters: Alameda, CA
Founded: 2004

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