Hybrid Sr. Manufacturing Engineer at Penumbra
Penumbra · Alameda, CA, United States Of America · Hybrid
- Office in Alameda, CA
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
Location and Salary
$125,000 to $175,000
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 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.
