Hardware Engineering Manager [F/M/X]

작업 내용

Job description
Mission Description

The hardware engineering manager develops and manages product design & development (engineering) competences that are necessary to the achievement of Biocartis business objectives.

Accountabilities

The hardware engineering manager

Is 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
facilitates the translation of technical topics to the OMPS Platform and Operations governance body to facilitate escalations, decision making and new project development;
facilitates 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;
Provides coaching (behavioral and/or technical) to the team;
Liaises with the OMPS Platform Lead in the establishment of a strategic product portfolio and roadmap;
Liaises with OMPS Platform project managers to facilitate project execution;
Liaises with the OMPS quality engineers to establish, maintain and ensure execution of design and development processes;
Establishes and manages a network of technical service and competence providers.
Profile Requirement

Profile requirements

Master 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).

Technical/Theoretical knowledge, skills, and expertise

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.

Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7500 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here’s what our recruitment process looks like:

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate’s shoes to ensure they have the best possible experience.
We look forward to meeting you!