This position is responsible for designing and developing new and improved manufacturing processes and ensuring efficient and effective product transfer into production within the medical disposable devices industry. Improve existing processes and implement new processes in the production line.
Job Responsibilities:
Develop and implement new manufacturing processes for production.
Perform Design of Experiments for process definition and optimize equipment parameters for new and/or existing processes.
Create documentation to support new and improved manufacturing processes.
Write and perform process validations (IQ, OQ, PQ) and validate methods for inspection, verification, and process controls.
Interface directly with assemblers, production supervisors, leads, and engineers.
Assesses process capabilities, innovates, and implements process improvements on key projects.
Applies technical knowledge to innovate, design, and develop processes, procedures, tooling, and/or automation.
Executes the functional deliverables associated with the NPI, Design Control, CAPA, and all Quality Systems.
As needed; plan, organize, and participate in all aspects of technical reviews.
Collaborate to ensure proper documentation is completed to meet quality systems requirements. (e.g., GOIs, BOMs, Routers, FMEAs, etc.).
Requirements: Candidates require process at least a bachelor's degree in mechanical engineering or biomedical engineering or related engineering degree.
Candidate requires at least 5 years of demonstrated process development/improvement activities - an advantage in the medical industry.
Equipment validations and process characterization and validation experience.
Prefer candidate from a medical device or other regulated industry experience.
Experience in FMEA documentation.
Demonstrated ability to develop processes from concept to production.
Excellent interpersonal and communication skills with good leadership abilities.
Excellent analytical and problem-solving skills in production environment, root cause analysis.
Performing investigation on product failures and defects.
Strong documentation skills.
This position is open to all candidates.