Sr. Manufacturing Engineer - Metals

Penumbra, Inc.; Alameda (CA); On-site; USD 125,000 - 175,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with employer match

Paid parental leave

11 paid holidays per year

Accrued vacation and sick time

Job summary

Penumbra, Inc. is seeking a Sr. Manufacturing Engineer to lead the engineering, design and development of neurovascular devices, and to provide manufacturing support for existing products.

The role involves developing, configuring, and troubleshooting processing and test equipment, and leading multidisciplinary teams on projects in Alameda, CA. Responsibilities include creating production drawings, directing project teams, ensuring QMS adherence, and training staff on new processes.

Qualifications

• Bachelor’s degree in engineering or related technical field with 4+ years of engineering level experience.
• 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.

Responsibilities

• Lead in engineering, design and development of new products or changes to existing products, processes and equipment.
• Interface with multidisciplinary teams overseeing neurovascular device development.
• Provide engineering support on existing devices for manufacturing.
• Develop, configure and troubleshoot processing and test equipment.
• Specify fixtures/tooling for automated equipment support.
• Create drawings for Production and R&D.
• Manage projects as Project Leader within a multidisciplinary team.
• Document manufacturing and production development processes.
• Train engineers, technicians and assemblers in new processes and methods.
• Adhere to QMS and applicable regulations; ensure department compliance.

Skills

Project leadership

Process improvement

Documentation

Strategic thinking

Problem solving

Education

Bachelor’s degree in engineering or related technical field

Master’s degree preferred

Tools

Computers & software applications

Job description

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

Location

Alameda, CA

Salary

$125,000 to $175,000

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 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.

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 see Penumbra's AAP Policy Statement.