Do you have experience with medical devices and process development? Contact Anaïs on 03 369 19 81 or send an e-mail to firstname.lastname@example.org
Our client is looking for a process engineer for the introduction of a new product. You are based in Beerse and will reside the device and packaging department.
Primary focus of this department is to provide technical competence and manufacturing excellence.
If you are interested you can always contact me: 03.369.19.81 or email@example.com
You will be responsible for:
- The implementation of one or more new combination products like co-packed kits, auto-injectors, syringe kits, ...
- Design transfer activities execution and documentation, including qualification of manufacturing equipment and process validation
- Collaborate closely with other NPI, engineering and Subject Matter Expert (SME) functions
- Process development for device assembly and packaging. Commercialisation activities including process and equipment qualification
- Verification and validation of test process and test fixtures to meet targeted test coverage and effectiveness
Preparation and oversight of packaging development activities including
We are looking for someone with:
- Master degree in engineering and/or sciences
- You are a born team player with strong organisational- and project skills
- Experience with FDA regulated Design Control, Change Control and ISO 13485, Quality management systems
- Broad scientific or engineering expertise with demonstrable results to deliver new products or sustain existing marketed products is required.
- Fluent in both Flemish and English
- A minimum of 5 years of experience in combination with on of the following area's:
- Products or medical device manufacturing
- Research & Development
Salary and Benefits
We can offer you a project of 4 months, with possible extension.