The main responsibilities for this position will be:
Material and process qualifications
Support Instrument (Medical Diagnostics Device) manufacturing and troubleshoot process related issues
Test, validate, and troubleshoot electrical or mechanical components for point of care Instruments (Medical Diagnostics Device)
Validate the systems and software used to develop or manufacture instruments and/or assay consumables used within instrumentation.
Initiate engineering change control
The ideal candidate will use industry best practices and their expertise in regulatory requirements to measure, analyze and specify requirements that lead to best-in-class quality products and design for manufacturability. We are looking for a highly motivated candidate, who can work cross-functionally to execute to the validation plan as well as material qualifications that come up as required.
IMPACT AND ORGANIZATIONAL CONTRIBUTION
Work with end users to develop consumable/assay/machine/software design specifications including user requirements specifications for all applications.
Represent the process & validation group in cross functional meetings.
Establish validation standards, support equipment/software/process requirements, develop V&V test protocols, lead pFMEA generation and effectively document results through the validation report.
Develop/qualify test methods fixtures to be able to test new/alternate components or troubleshoot issues.
Coordinate with vendors/suppliers to create validation/material qualification requirements, review, and approve final reports.
Create and maintain project timelines for validations/material qualifications that include risk mitigations to achieve required timelines.
Work with the Quality organization to optimize preventative maintenance and calibration process based on the validation requirements/plan.
Utilize statistical tools, to determine whether the systems, process or materials meet requirements.
Ability to identify root cause of failures or deviations to plan and come up with corrective actions.
Effectively partners with and motivates enabling support teams to improve operations for the advancement of the whole site and company.
Strong ability to do root-cause problem solving, and implementation of effective preventative action.
Actively contribute to meeting business objectives around compliance, cost savings, and potentially capital spend requirements.
EDUCATION AND EXPERIENCE
Bachelor's Degree in Mechanical/Electrical Engineering with 3+ years of experience in a manufacturing environment
Experience in regulated industries (Food and Drug Administration, USDA) is required.
Ability to read/understand/create drawings and schematics.
Experience with Microsoft Excel (VBA programming) and SolidWorks is a plus.
Experience with software validation is a plus.
Demonstrated ability to interact effectively with all levels of colleagues and management across organizational boundaries.
Candidate must possess flexibility and agility to respond to constantly changing conditions and priorities.
Must be willing to quickly learn and become proficient in common systems used to manage the business - to include production schedule, quality deviations, ERP system (SAP preferred), and change control.
Experience with Non-Conformance report (NCR) and Corrective Action and Preventative Action (CAPA) is preferred.
Experience with operating and programming CMM (Coordinate Measuring Machines) is preferred.
Experience with injection molded plastics is preferred.
Experience dealing with outside vendors or CMOs is preferred.
Work Environment: Colleague must work onsite, be able to lift at least 50 pounds, and work near moving mechanical parts with moderate noise level where the use of hearing protection is optional, and eye protection is required.
The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in [ California ] Base pay may vary based on location and other factors.
Base Pay Range: $73,000 - $112,000
This position is eligible for short-term incentive compensation.
We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and retirement savings benefits along with paid holidays, vacation and disability insurance.
Full time
Regular
Colleague
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