Hardware Engineering Manager

il y a 3 semaines


belgium belgique WhatJobs Temps plein

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Hardware Engineering Manager (OPEN for consultancy profiles)

Client: Biocartis

Location: Mechelen, Belgium

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 a product design and development role; at least 3 years in a leadership or management position in a regulated design and development environment (e.g. ISO13485, FDA 21 CFR 820). Non-medical regulated experience (e.g. aerospace, automotive, defense) will be considered as well.

Education: Master degree in civil engineering, bio-engineering, mechanical engineering, electro-mechanical engineering, physics or equivalent by experience/training.

Accountabilities:

  1. Accountable for resource and competence management within the OMPS platform hardware team.
  2. Initiates necessary recruitment procedures and liaises with the HR team.
  3. Ensures proper resource allocation to OMPS Platform and test development life cycle projects.
  4. Ensures sufficient competences within the team to effectively execute on OMPS Platform projects.
  5. Ensures sufficient competences within the team to effectively interface with Biocartis product suppliers.
  6. Ensures implementation of engagement and/or performance review process in accordance with HR processes.
  7. Facilitates the translation of technical topics to the OMPS Platform and Operations governance body.
  8. Facilitates the establishment and maintenance of design and development processes in accordance with Biocartis quality management system processes.
  9. Provides coaching (behavioral and/or technical) to the team.
  10. Liaises with the OMPS Platform Lead in the establishment of a strategic product portfolio and roadmap.
  11. Liaises with OMPS Platform project managers to facilitate project execution.
  12. Liaises with the OMPS quality engineers to establish, maintain and ensure execution of design and development processes.
  13. Establishes and manages a network of technical service and competence providers.

Profile requirements:

  1. Master degree in civil engineering, bio-engineering, mechanical engineering, electro-mechanical engineering, physics or equivalent by experience/training.
  2. At least 7 years experience in a product design and development role.
  3. At least 3 years experience in a leadership or management position in a regulated design and development environment.

Technical/Theoretical knowledge, skills, and expertise:

  1. Profound knowledge of the relevant regulatory framework (ISO 13485, ISO 14971, FDA 820.30).
  2. Demonstrated practical experience with systems engineering principles.
  3. Profound knowledge and experience in mechatronics.
  4. Experience with software engineering or injection molding technology is an asset.
  5. Software and database applications: MS Office - eQMS software (e.g. MasterControl, Scilife).
  6. Languages: English (professional working proficiency), Dutch is an asset.

Interested to join a value-driven organisation?

We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and your job. Your input is highly appreciated. We offer a fitting compensation package which includes a Flexible Income Plan, as well as flexibility due to our hybrid work regime.

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