Job Title: Hardware Engineering Director
We are seeking an experienced Hardware Engineering Manager to lead our team in the development of innovative hardware solutions.
Responsibilities:
* Resource and Competence Management:
o Initiate recruitment procedures and collaborate with HR for a smooth process.
o Ensure adequate resource allocation for OMPS Platform and test development life cycle projects.
o Maintain sufficient competences within the team to effectively execute OMPS Platform projects.
o Interface with Biocartis product suppliers, ensuring effective collaboration.
* Translation of Technical Topics:
o Foster open communication between technical teams and Operations governance body.
o Educate stakeholders on key technical topics.
* Design and Development Processes:
o Establish and maintain design and development processes for Biocartis platform products.
o Ensure compliance with quality management system processes.
* Coaching and Liaison:
o Provide coaching to team members.
o Liaise with OMPS Platform Lead for strategic product portfolio and roadmap development.
o Collaborate with OMPS quality engineers for design and development execution.
Requirements:
* Master's degree in a relevant field (e.g., civil engineering, bio-engineering, mechanical engineering).
* At least 7 years of experience in product design and development.
* 3+ years of leadership or management experience in regulated environments (ISO13485, FDA 21 CFR 820).
* Profound knowledge of regulatory frameworks (ISO 13485, ISO 14971, FDA 820.30).
* Demonstrated practical experience with systems engineering principles.
* Strong understanding of mechatronics.
* Experience with software engineering or injection molding technology is an asset.
Qualifications:
* Professional proficiency in English; Dutch is an asset.