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Manufacturing Engineer

Michael Bailey Associates - UK Contracts

Posted on Apr 21, 2021 by Michael Bailey Associates - UK Contracts

Not Specified, Switzerland
Engineering
3 May 2021
Annual Salary
Contract/Project


Working for a Medical Device client In Switzerland


Title: Manufacturing Engineer


Position overview


The Manufacturing Engineer is responsible for all activities related to the manufacturing processes (assembly, vacuum drying) of our surgical implants. He/she acts as main point of contact of the Production Department and drives process improvement to ensure industrial performance.


Tasks & Responsibilities:


* Provide day to day engineering support to the Production Department


* Propose and lead improvement projects (process, tooling)


* Support the integration of line extension projects into manufacturing


* Support capital investment requests


* Develops validation strategy and write validation documentation per company validation policies and regulations


* Coordinates and execute validations (SAT, FAT, IQ, OQ, PQ)


* Actively participate to Non-Conformance and CAPA process related to manufacturing


* Ensure engineering activities are carried out in compliance with company policies and regulations


* Ensure all Health Safety and Environment requirements are met, and new standards are implemented


* Review weekly and monthly performance metrics to set improvement strategy and determine appropriate actions


Qualifications & Experience


Experience:


* A minimum bachelor's degree in Engineering or related technical discipline. A Master's or other advanced degree is a plus.


* A minimum of 3 years of experience in Manufacturing Engineering and equipment validation is required.


* Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement


System Analysis, SPC, DOEs, Reliability, etc.


* Technical training in Project Management methodologies


* Experience working in both an FDA and European regulatory environment is preferred. Working knowledge of GMPs, QSR, 21 CFR 820, MDD, ISO13485 and ISO14971 is required. MDR is a plus.


Interpersonal skills/characteristics:


* Ability to Inspire and mobilize people and team


* Ability to "think out of the box", flexibility, open-minded, team spirit and "can do" attitude are required personal skills.


Good technical understanding of manufacturing equipment and processes is required.


* Proven evidences of multi-tasking and proven evidences of taking ownership of action outside of its direct field of responsibilities are required.


* Excellent problem solving, decision-making, and root cause analysis skills are required.


Minimum Language required:


* Fluency in English is required.


* Fluency in French is required.


Michael Bailey International is acting as an Employment Business in relation to this vacancy.




Reference: 1174008418

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