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Hardware Engineering Manager (OPEN for consultancy profiles), Belgium
Client: Biocartis
Location: Mechelen, Belgium
Job Category: Other
EU work permit required: Yes
Job Reference: [Not provided]
Job Views: 3
Posted: 31.05.2024
Expiry Date: 15.07.2024
Job Description:
Share Publication date 15 July 2024
Workplace type: Hybrid
Travel percentage: 0%
Department: R&D - Engineering (software, system, mechanical)
Function type: Full-time
Contract type: Employee
Experience 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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