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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
3 May 2021
Annual Salary

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


* 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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