Sr Manufacturing Engineer

Roseville, CAfull timeOn Site

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senior

$113k–$157k

H1B: no

Penumbrainc The Sr Manufacturing Engineer leads engineering, design, and development of new or modified medical device products and processes. This role manages projects independently and provides technical support within multidisciplinary teams.

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 *

Qualification

Understand relevant securityMaster’s degree preferredGeneral officeWillingness and ability to work on siteBusiness travel from 0% - 10%Working ConditionsAnnual Base Salary Range

Required

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
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
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
General office, laboratory, and clean room environments.
Willingness and ability to work on site.
Business travel from 0% - 10%