Manufacturing Engineer - Systems

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 transfers. The role requires the ability to collaborate effectively across functions ranging from Quality and Design to Manufacturing in the US and Mexico.
Essential Job Duties
Lead manufacturing line transfer projects, including:
Lead project management effectively, including monitoring schedules for multiple functions across two plants
Procure, assemble, and qualify custom mechanical and electromechanical equipment
Improve equipment documentation and design as needed for continuous improvement in preparation for further transfers
Develop an in-depth understanding of our manufacturing processes, and transfer knowledge to new engineers and assemblers from a remote location to facilitate an effective transfer
Troubleshoot electromechanical equipment problems, including collaboration with third party equipment makers as needed, e.g. braiders, laminators, or testing equipment
Support several Ion manufacturing lines including:
Establish regular communication with the production team to ensure they have the best support possible for both short and long term needs
Manage product reliability improvements from concept to implementation
Identify, design, qualify, document and introduce assembly/test fixtures and equipment
Improve process flows of Ion instrument manufacturing lines to optimize for reliability, efficiency, capacity, cost, and technician safety
Execute and mentor others in manufacturing process validations, process FMEAs, and other elements associated with production Master Validation Plans
Provide product and process Design for Manufacturing/Assembly (DFX) input to enhance manufacturability, and lead improvement implementations
Manage manufacturing strategy and production capability for Ion Instrument lines to minimize customer backorders
Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation
Provide technical support for failure analyses and root cause investigations of product failures
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
Required Skills and Experience
Strong technical problem solving and analytical skills
Familiar with various component manufacturing processes (machining , injection molding & MIM, stamping, coining, extrusion)
Familiar with mechanical CAD software (SolidWorks)
Familiar with Process and Equipment Qualifications (IQ/OQ/PQ/PPQ)
Strong organizational skills and ability to work on several fast-paced projects simultaneously
Mechanical design and analysis skills, including statics, dynamics, kinematics, strength of materials, and stress analysis is a plus
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
25% travel (including international) is required
Required Education and Training
B.S. degree in engineering discipline, M.S. preferred

Employment type
Full-time

Work arrangement
No