About company:We are a Belgian engineering consulting firm that assists SMEs and large industrial organizations in bringing their innovation and R&D initiatives to life.Job Description:As a Hardware Engineering Manager, you:Are accountable for resource and competence management within the OMPS platform hardware team: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.Facilitate the translation of technical topics to the OMPS Platform and Operations governance body to facilitate escalations, decision making and new project development.Facilitate 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.Provide coaching (behavioral and/or technical) to the team.Liaise with the OMPS Platform Lead in the establishment of a strategic product portfolio and roadmap.Liaise with OMPS Platform project managers to facilitate project execution.Liaise with the OMPS quality engineers to establish, maintain and ensure execution of design and development processes.Establish and manage a network of technical service and competence providers.Required Qualifications: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).Profound knowledge of the relevant regulatory framework: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 molding technology is an asset.Software and database applications: MS Office - eQMS software (e.g. MasterControl, Scilife).Legislation and regulation:ISO13485 Medical devices – Quality management systems – Requirements for regulatory purposes.FDA 21 CFR 820.30 – Design Controls: design planning, input, output, verification, validation, transfer, review, change and risk management.ISO14971 Medical devices – Application of risk management to medical devices.IVDR – In Vitro Diagnostics Regulation.Languages: English: professional working proficiency both spoken and written, Dutch is an asset.
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