374 days ago on sire-search.com

Sr Validation Engineer Injection Devices

SIRE Life Sciences

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Sr Validation Engineer Injection Devices

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!


Our client is a professional Medical Devices organization, based in Genf Switzerland.

The company is a Global Healthcare company, with worldwide branches. Their medical devices operations are headquarters in the West of Switzerland, near Geneva.


Overall, you will be responsible for setting out the full Validation & Verification strategy. Because my client is making extensive use of CMO's, a strong validation and verification strategy is key in making sure the medical devices will reach the market in the right order. You will be overviewing all test plans set up by the CMO's, making sure they are in line with your strategy. You will be defining all the System Test requirements for the whole design.
Because of the size of the medical devices operations of this company, you will have to effectively communicating with both clients and team members on all different levels of seniority within the company.


- Setting up the validation & verification strategy of the whole range of Injection devices the company has to offer.
- Defining End-to-End System Test Requirements of projects
- Develop and execute protocols for validation and verification
- Plan and implement QA and QC for test projects
- Set up a defect and test management tool, and to manage all test activities (resources, timing, cost, quality and risk).


- A background in Mechanical or Electronic Engineering.
- Experience in the Medical Devices, Automotive or Aerospace industry.
- Fluency in English is required, good German and/or French is a big plus.
- The candidate should have experience with FDA 21 CFR 820, ISO 13485, IEC62304 and ISO 11608, or alike if the candidate is from the Aerospace or Automotive industry.
- From a personal perspective, a strong team spirit, good leadership skills, being able to stand your ground and make sure the designed strategy will be implemented company-wide, are required.
- Previous working experience in the US is a big plus.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Matthias Kunkel.