manufacturing engineer à Neuchatel

publié
contact
Barbara Sorce, Bâle Professionals Health Care & Life Sciences
type d'emploi
contract
postuler >

job details

publié
lieu
neuchatel, neuchâtel
secteur
life sciences
type d'emploi
contract
référence
15760
contact
barbara sorce, bâle professionals health care & life sciences
téléphone
058 201 55 50

description du poste

For our medical device client in Neuchatel, we are looking for a

Manufacturing Engineer

Contract: 6 months with possibility of extensionStart: asap

 

Position overview

The Manufacturing Engineer is responsible for all activities related to the manufacturing processes (assembly, vacuum drying) of the surgical implants. He acts as the 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.
  • 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.
  • Fluency in English is required.
  • Fluency in French is required.