Job Title - Medical Device Manufacturing Engineer
Job Location - 9775 Toledo Way, Irvine, California (Fully Onsite)
Type: W2 contract
Location: Based in Toledo with potential travel to a second site.
Additional support might be required at a Santa Ana location, which is within a 10-mile radius.
Responsibilities may include the following and other duties may be assigned.
Responsible for production support engineering with respect to testing methods, procedures, and problems; device specification and yield problems; minor redesign of devices and masks; analysis of customer returns; supplier related engineering changes and optimizing device production relative to cost constraints.
Assumes responsibility for device and/or internally produced or externally purchased components after transfer into high volume production and usually responsible for entire device manufacturing operations other than wafer fabrication.
May assist customer in device usage problems or customer testing of complex devices.
Position Overview:
Role Type: Contingent role to support manufacturing processes and improvement projects.
Experience Required: 2-3 years of experience in manufacturing engineering, with preference for those with medical device experience.
Key Responsibilities:
Support regular manufacturing operations.
Collaborate closely with manufacturing operators to monitor daily production.
Assist in developing tooling or manufacturing processes.
Conduct validation activities, such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Perform root cause investigations on non-conformances.
Day-to-Day Responsibilities:
Majority of time will be spent providing operational support and resolving non-conformances.
Limited involvement in validation activities, primarily when required.
Support may involve rotational travel between Toledo and Santa Ana, depending on project needs.
Qualifications: Preference for candidates with medical device manufacturing experience, but candidates from other regulated industries may be considered.
Must be able to take on the role immediately due to the urgent need for manufacturing support.
Overqualification Concerns:
Candidates with more than 8 years of experience may be considered, but the priority is on candidates with the 2–3-year experience range for this role.
Key Qualities Sought:
Proficiency in cycle time management and understanding of the process flow.
Ability to quickly adapt and support immediate manufacturing needs.
Additional Notes: Candidates with a strong manufacturing background, especially in medical devices, will be given priority.