- Experience Level
- Experienced (non-manager)
Working for a Medical Device client In Switzerland -
Title: Manufacturing Engineer
The Manufacturing Engineer is responsible for all activities related to the manufacturing processes (assembly, vacuum drying) of our surgical implants. He 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.