Senior Medical Device Manufacturing Engineer — On‑Site Lead

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

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.