MANUFACTURING ENGINEER 2
Role:
Manufacturing Engineer Needles, Accessories,& Endoscopes Location:
Sunnyvale, CA 94086 Contract Primary Function of Position:
This entry level manufacturing engineer will support multiple manufacturing lines for both mature and new instruments and accessories for the Ion platform.
This engineer must be able to support existing manufacturing lines, recommend and implement improved manufacturing processes, and lead manufacturing line duplications and transfers.
The role requires the ability to collaborate effectively across functions ranging from Quality and Design to Manufacturing in the US and Mexico.
Roles and
Responsibilities:
Support several Ion manufacturing lines including:
o Establish regular communication with the production team to ensure they have the best support possible for both short and long term needs o Manage product reliability improvements from concept to implementation o Identify, design, qualify, document and introduce assembly/test fixtures and equipment o Improve process flows of Ion instrument manufacturing lines to optimize for reliability, efficiency, capacity, cost, and technician safety o Execute and mentor others in manufacturing process validations, process FMEAs, and other elements associated with production Master Validation Plans o Provide product and process Design for Manufacturing/Assembly (DFX) input to enhance manufacturability, and lead improvement implementations o Manage manufacturing strategy and production capability for Ion Instrument lines to minimize customer backorders o Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation o Provide technical support for failure analyses and root cause investigations of product failures o Procure, assemble, and qualify custom mechanical and electromechanical equipment o Troubleshoot electromechanical equipment problems, including collaboration with third party equipment makers as needed, e.
g.
pneumatic presses, leak testers, laminators, or other custom manufacturing equipment Contribute to the establishment of group and individual objectives consistent with overall product development goals, including priority setting, establishment of metrics, and effectively communicating progress Provide resource budget estimates for product and process improvements, tooling development, and testing Works with Quality and Regulatory to ensure that the team follows appropriate GMP, design history file (DHF), and device history record (DHR) guidelines per FDA requirements Skill/Job Requirements:
B.
S.
degree in engineering discipline, preferably Biomedical or Mechanical, M.
S.
preferred Strong technical problem solving and analytical skills General familiarity with various component manufacturing processes (e.
g.
machining, plastic injection molding, extrusion) Familiar with mechanical CAD software (SolidWorks preferred) Strong organizational skills and ability to work on several fast-paced projects simultaneously Able to communicate effectively and professionally with cross-functional peers, executive leadership, internal customers, and external suppliers Prior experience with Design Control processes for medical devices and/or clinical applications of the surgical instruments, and/or automated equipment design is a plus Experienced in ISO 13485, ISO 9001, or medical device manufacturing environment, Six Sigma is a plus On site 100% 5 days per week Ability to travel 15% Recommended Skills Analytical Biomedical Engineering Business Process Improvement Cad Clinical Works Communication Estimated Salary: $20 to $28 per hour based on qualifications.
Manufacturing Engineer Needles, Accessories,& Endoscopes Location:
Sunnyvale, CA 94086 Contract Primary Function of Position:
This entry level manufacturing engineer will support multiple manufacturing lines for both mature and new instruments and accessories for the Ion platform.
This engineer must be able to support existing manufacturing lines, recommend and implement improved manufacturing processes, and lead manufacturing line duplications and transfers.
The role requires the ability to collaborate effectively across functions ranging from Quality and Design to Manufacturing in the US and Mexico.
Roles and
Responsibilities:
Support several Ion manufacturing lines including:
o Establish regular communication with the production team to ensure they have the best support possible for both short and long term needs o Manage product reliability improvements from concept to implementation o Identify, design, qualify, document and introduce assembly/test fixtures and equipment o Improve process flows of Ion instrument manufacturing lines to optimize for reliability, efficiency, capacity, cost, and technician safety o Execute and mentor others in manufacturing process validations, process FMEAs, and other elements associated with production Master Validation Plans o Provide product and process Design for Manufacturing/Assembly (DFX) input to enhance manufacturability, and lead improvement implementations o Manage manufacturing strategy and production capability for Ion Instrument lines to minimize customer backorders o Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation o Provide technical support for failure analyses and root cause investigations of product failures o Procure, assemble, and qualify custom mechanical and electromechanical equipment o Troubleshoot electromechanical equipment problems, including collaboration with third party equipment makers as needed, e.
g.
pneumatic presses, leak testers, laminators, or other custom manufacturing equipment Contribute to the establishment of group and individual objectives consistent with overall product development goals, including priority setting, establishment of metrics, and effectively communicating progress Provide resource budget estimates for product and process improvements, tooling development, and testing Works with Quality and Regulatory to ensure that the team follows appropriate GMP, design history file (DHF), and device history record (DHR) guidelines per FDA requirements Skill/Job Requirements:
B.
S.
degree in engineering discipline, preferably Biomedical or Mechanical, M.
S.
preferred Strong technical problem solving and analytical skills General familiarity with various component manufacturing processes (e.
g.
machining, plastic injection molding, extrusion) Familiar with mechanical CAD software (SolidWorks preferred) Strong organizational skills and ability to work on several fast-paced projects simultaneously Able to communicate effectively and professionally with cross-functional peers, executive leadership, internal customers, and external suppliers Prior experience with Design Control processes for medical devices and/or clinical applications of the surgical instruments, and/or automated equipment design is a plus Experienced in ISO 13485, ISO 9001, or medical device manufacturing environment, Six Sigma is a plus On site 100% 5 days per week Ability to travel 15% Recommended Skills Analytical Biomedical Engineering Business Process Improvement Cad Clinical Works Communication Estimated Salary: $20 to $28 per hour based on qualifications.
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