Responsible for the implementation and the optimization of robust manufacturing processes in Production ensuring that safety, effectiveness, quality and reliability of the devices are met.
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Lead PFMEA activities in coordination with other stakeholders.
Generate and validate work instructions and test procedures.
Responsible for process validation, IQ, OQ, PQ and to get the manufacturing equipment compliant for the production.
Specify, design, and install equipment, tooling and fixtures used in production.
Participate in DFM and DFA activities to define manufacturing processes for new product and product improvement programs.
Develop Critical to Assembly (CTA) requirements as required for manufacturing processes.
Identify Key Performance Indicators and process capability metrics using Measurement System Analysis (MSA), Gage Repeatability and Reproducibility (GR&R), and Statistical Process Control (SPC) techniques.
Knowledge, skills and abilities required
* Broad technical experience in FDA/ISO regulated biomedical device environment, manufacturing processes and equipment of disposables, polymeric, testing and characterization methods, measurement systems;
* 10+ years of experience in Process development and/or Process Engineering/Manufacturing of Class II and/or Class III medical devices;
* Demonstrated experience in the selection and qualification of assembly equipment and automation, automated assembly methods, robotics, PLCs, automated inspection, fixture design, injection molding and plastic joining techniques, including ultrasonic/RF/laser welding and adhesive/solvent bonding;
* Lean Six Sigma experience and knowledge of statistical data analysis techniques is a plus. Experience using xjrgpwk Minitab or similar statistical evaluation software/tools preferred;
* Effective analytical and decision-making skills;
* Detail oriented with strong organizational skills;
* Ability to work in an international and fast moving environment;
* Highly motivated to enhance products, techniques and consequently the life of the patients;
* Excellent communication skills in English;
* Degree in mechanical / mechatronic / biomedical / physics engineering;
* Good knowledge of Microsoft Office suite;
* Willingness to relocate to Mirandola, Italy