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Hardware Engineering Manager

  1. Antwerp
Antwerpen
  1. Contract
Competitive
  1. CAPEX Projects
35483
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Hardware Engineering Manager - Belgium - 12-Month Contract 

Our client is a molecular Diagnostics company committed to molecular testing with its unique Idylla Platform. They provide next generation diagnostic solutions, aimed at improving clinical practice for the benefit of patients, clinicians, and the healthcare industry, focusing on Oncology. Biocartis offers tests supporting melanoma, colorectal and lung cancer, as well as tests for SARS-CoV-2 and sepsis.


Responsibilities:
  • Initiates necessary recruitment procedures and liaise with the HR team in the process
  • Ensures proper resource allocation to OMPS Platform and test development life cycle projects
  • Ensures sufficient competences within the team to effectively execute on OMPS Platform projects
  • Ensures sufficient competences within the team to effectively interface with Biocartis product suppliers (instrumentation CMO, cartridge part supplier and internal manufacturing line)
  • Ensure implementation of engagement and/or performance review process in accordance with HR processes
  • facilitates the translation of technical topics to the OMPS Platform and Operations governance body to facilitate escalations, decision making and new project development;
  • facilitates the establishment and maintenance of the design and development processes and history file of Biocartis platform products (disposables, instrumentation, software, tools and accessories) in accordance with the appropriate Biocartis quality management system processes.
  • Provides coaching (behavioral and/or technical) to the team.
  • Liaises with the OMPS Platform Lead in the establishment of a strategic product portfolio and roadmap.


Technical Knowledge and Skills required.
  • Master’s degree in civil engineering, bio-engineering, mechanical engineering, electro-mechanical engineering, physics or equivalent by experience/training;
  • At least 7 years’ experience in a product design and development role
  • At least 3 years’ experience in a leadership or management position in a regulated design and development environment (e.g. ISO13485, FDA 21 CFR 820). NB: experience in a non-medical regulated environment will be considered as well (e.g. aerospace, automotive, defense).
  • Design and development according to ISO 13485
  • Risk management according to ISO 14971
  • Design controls according to FDA 820.30
  • Demonstrated practical experience with systems engineering principles.
  • Profound knowledge and experience in mechatronics.
  • Experience with software engineering or injection moulding technology is an asset.
  • Software and database applications : MS Office - eQMS software (e.g. MasterControl, Scilife)
 
If this role is of interest to you, please apply now! 

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