Job Description
The Manufacturing Engineer will be responsible for performing a variety of technical and support roles to the Production / Manufacturing department. The role requires an analytical approach to problem-solving, effective communication skills, and the ability to work in a team environment.
Key Responsibilities:
1. Provide technical support on all product and processing related issues;
/li-
close specification procurement installation validation of manufacturing equipment including on site Factory Acceptance Testing of equipment.
Set up Preventive Maintenance Calibration routines provide ongoing day-to-day support to Production continually seeking drive improvement operation performance maintaining highest levels regulatory conformance effectively trouble shoot production-related issues implementing "robust permanent fix" solutions establish maintain appropriate manufacturing documentation Equipment documentation p FMEAs TMVs Bills Materials Part Numbers Product routings Work Instructions Manufacturing procedures Logs Set order Products Components Consumables Material necessary for validation-production Manage Tooling Equipment spare parts inventory Support manufacturing capacity Draft IQOQ protocols Develop execute required validations line with regulatory requirements include Equipment Process Product validations Partner R D Quality Operations ensure transition products through R D product approval-manufacturing scale-up smooth timely cost-effective Qualifications Engineering Degree equivalent A minimum years' engineering experience working similar role Catheter manufacturing knowledge highly desirable Strong understanding setup maintenance balloon manufactured processes Experience validation equipment design Lean highly desirable Competencies Attributes Proven expertise competence across aspects.lean Demonstrated expertise detailed knowledge medical device industry Has conducted previously regulated environment Effective knowledge regulatory environment which business operates Proven written oral communication skills preparation competent Business cases An analytical approach problem-solving Good Communication capabilities represent company customer representatives bodies Is creative Continually learning exploring new ideas High flexibility requried respect duties prioritization activities Self-starter applies own initiative situations Good team player work well Team Environment Capacity maintain confidentiality externally Ability stay connected multiple projects simultaneously