Katalyst HealthCares & Life SciencesGainesville, FL
serp_jobs.job_card.full_time
Protocol Review & Compliance : Study and assess Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for regulatory and procedura...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
serp_jobs.job_card.promoted
Drainage Engineer
VolkertGainesville, FL, United States
serp_jobs.job_card.full_time
Are we the road to your future?.We are currently searching for an experienced.To be considered for this position, applicants musthave, at minimum, a Bachelor's of Science in Civil Engineering.Colle...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Network Engineer II
Northeast Georgia Medical CenterGainesville, Florida, USA
serp_jobs.job_card.full_time
Northeast Georgia Health System is rooted in a foundation of improving the health of our communities.Network Engineer II Northeast Georgia Medical Center Inc.
Service the organization patients and ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
Civil Engineer
Liberty JobsGainesville, FL
serp_jobs.job_card.full_time
Proficient in Civil 3D software.Strong project management and communication skills.Ability to work collaboratively with multidisciplinary teams.
Design and oversee civil engineering projects.Ensure ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Manufacturing Engineer
Katalyst Healthcares & Life SciencesGainesville, FL, United States
serp_jobs.job_card.full_time
Protocol Review & Compliance : Study and assess Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for regulatory and procedura...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Entry-Level Engineer
The Whiting-Turner Contracting CompanyGainesville, FL, United States
serp_jobs.job_card.full_time
The Whiting-Turner Contracting Company is an Equal Opportunity Employer, including the disabled and veterans.Whiting-Turner Entry-Level Engineers are team members who help manage all aspects of con...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Maintenance Engineer
Peachtree GroupGainesville, FL, US
serp_jobs.job_card.full_time
The Maintenance Engineer position is responsible for providing technical and maintenance services throughout the hotel to keep the hotel’s general equipment and systems in excellent condition.Appro...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Validation Coordinator
LifeSouthGainesville, FL
serp_jobs.job_card.full_time
Job Type Full-time Description.Are you looking to make a difference in your community and help save lives? Seeking to work for a non-profit whose values include safety, teamwork, and stewardship? D...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
serp_jobs.job_card.promoted
Manufacturing Engineer
Advita OrthoGainesville, FL, United States
serp_jobs.job_card.full_time +1
Senior Manager Manufacturing Engineering.Create and maintain the lowest cost, highest quality machining & manufacturing processes, tooling and supporting documentation for all parts produced.Suppor...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Civil Engineer (Professional Engineer)
GpacGainesville, Florida, United States
serp_jobs.job_card.full_time
A well-established, growing engineering firm, with a location in the area, is looking for a Professional Civil Engineer.They work hard to ensure projects are planned, designed, and managed to meet ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
serp_jobs.job_card.promoted
Automation Engineer
Jones Lang LaSalle IP, Inc.Gainesville, FL, United States
serp_jobs.job_card.full_time
JLL empowers you to shape a brighter way.Our people at JLL and JLL Technologies are shaping the future of real estate for a better world by combining world class services, advisory and technology f...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
serp_jobs.job_card.promoted
Maintenance Engineer
Property ManagementGainesville, Florida, USA
serp_jobs.job_card.full_time
The Maintenance Engineer position is responsible for providing technical and maintenance services throughout the hotel to keep the hotels general equipment and systems in excellent condition.Approa...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Entry-Level Engineer
Whiting-Turner Contracting CompanyGainesville, FL, United States
serp_jobs.job_card.full_time
The Whiting-Turner Contracting Company is an Equal Opportunity Employer, including the disabled and veterans.Whiting-Turner Entry-Level Engineers are team members who help manage all aspects of con...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
serp_jobs.job_card.promoted
Security Engineer
City of GainesvilleGainesville, Florida, USA
serp_jobs.job_card.full_time
If you are an Internal City Employee Retiree or Dependent / Survivor of a City Employee please apply internally via Career Icon in your Workday account.
Make a difference in the community you live in! ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
serp_jobs.job_card.promoted
Principal Backend Engineer
FeathrGainesville, Florida, United States
serp_jobs.job_card.full_time
As the Nonprofit Marketing Platform.Feathr is purpose-built to help our customers unlock more results, time, and confidence.
Feathr's software marketing platform equips nonprofits with the tools the...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Automation Engineer
JLLGainesville, FL
serp_jobs.job_card.full_time
JLL empowers you to shape a brighter way.Our people at JLL and JLL Technologies are shaping the future of real estate for a better world by combining world class services, advisory and technology f...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
serp_jobs.job_card.promoted
Manufacturing Engineer
Katalyst Healthcares and Life SciencesGainesville, FL, United States
serp_jobs.job_card.full_time
Protocol Review & Compliance : Study and assess Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for regulatory and procedura...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
serp_jobs.job_card.promoted
Software Development Engineer
AmazonGainesville, FL, USA
serp_jobs.job_card.full_time
Join Amazon's engineering team and help us build innovative solutions to complex problems.As a Software Development Engineer, you will design, develop, and test software applications and services.W...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Data Engineer
Digital Media SolutionsUSA, FL
serp_jobs.filters.remote
serp_jobs.job_card.full_time
Based out of Clearwater, FL and a leading provider of technology-enabled digital performance advertising solutions, Digital Media Solutions is looking to bring aboard a.
Technology team! If you are ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Katalyst HealthCares & Life SciencesGainesville, FL
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
serp_jobs.job_card.full_time
job_description.job_card.job_description
Job Description :
Protocol Review & Compliance : Study and assess Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for regulatory and procedural compliance.
Process Audits & Documentation : Conduct thorough audits of manufacturing processes to identify documentation gaps. Update Quality Management System (QMS) documents to reflect findings and ensure alignment with current standards.
Process Optimization : Design and execute Design of Experiments (DoE) to optimize process parameters for CNC Machining and DCM. Establish and document robust process parameters and operating windows.
Validation Execution : Execute or re-execute validation protocols including sample measurements and data collection. Generate comprehensive IQ, OQ, PQ reports based on validation activities.
Statistical Analysis : Run statistical reports to analyze process capability, variability, and performance trends.
Change Management : Lead and document change management activities related to Continuous Monitoring : Monitor validated process parameters to ensure equipment and processes remain in a validated state. Implement controls and corrective actions as needed to maintain compliance.
process improvements and equipment modifications.
Responsibilities :
Experience working in QMS and ERP systems.
Experience with IQ / OQ / PQ / TMV preferred.
Worked with cross functional teams.
Collaborate with Quality Engineering to provide manufacturing support.
Responsible for providing manufacturing engineering support to specific projects including change analysis, risk analysis, and manufacturing readiness.
Should be experienced in medical device manufacturing assembly lines.
Troubleshoot and resolve issues relating to the safety, efficacy, quality, cost, or delivery of components and finished devices.
Need to conduct qualification, verification, and validation activities to produce medical devices.
Need to be responsible for completing engineering work and contribute to new product development teams and product support, typically including the following activities : technology development, test of materials or products, preparation of specifications, six sigma, process studies, process improvements, and report preparation.
Participate on cross-functional project teams. Coordinate, manage, and document project work and progress, and recommend appropriate revisions.
Work with CFT teams in troubleshooting problems on the production floor.
Requirements :
Bachelor's or master's degree in mechanical engineering, Biomedical Engineering, or related field.
years of experience in medical device manufacturing, with hands-on experience in CNC Machining and DCM.
Strong understanding of FDA, ISO , and GMP requirements.
Proficiency in statistical analysis tools (, Minitab, JMP).
Experience with QMS systems and documentation practices.
Excellent analytical, problem-solving, and communication skills.