Social network you want to login/join with:Hardware Engineering Manager (OPEN for consultancy profiles), BelgiumClient: BiocartisLocation: Mechelen, BelgiumJob Category: OtherEU work permit required: YesJob Reference: (Not provided)Job Views: 3Posted: 31.05.2024Expiry Date: 15.07.2024Job Description:Share Publication date 15 July 2024Workplace type: HybridTravel percentage: 0%Department: R&D - Engineering (software, system, mechanical)Function type: Full-timeContract type: EmployeeExperience required: At least 7 years in product design and development, with 3+ years in leadership in regulated environments (e.g., ISO13485, FDA 21 CFR 820). Experience in non-medical regulated fields like aerospace, automotive, or defense will also be considered.Education: Master’s degree in civil, bio-, mechanical, electro-mechanical engineering, physics, or equivalent by experience/training.Responsibilities:Manage resources and competencies within the hardware team for the OMPS platform.Recruitment and liaising with HR.Allocate resources effectively for projects.Ensure team has necessary skills for project execution and interface with suppliers.Implement engagement and performance reviews.Translate technical topics for governance and decision-making.Maintain design and development processes and documentation per quality standards.Provide coaching to team members.Collaborate on product portfolio and roadmap.Facilitate project execution and quality assurance.Establish and manage a network of technical service providers.Profile requirements:Master’s degree in relevant engineering or equivalent experience.7+ years in product design and development.3+ years in leadership in regulated environments.Technical knowledge and skills:Profound knowledge of ISO 13485, ISO 14971, FDA 820.30.Experience with systems engineering and mechatronics.Knowledge in software engineering or injection molding is a plus.Proficiency with MS Office and eQMS software.Understanding of relevant legislation and regulations.Languages: English (professional), Dutch (asset).Why join us?We offer a challenging role in a dynamic biotech environment, with opportunities to shape your work, a competitive package, and flexible hybrid work arrangements.
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