manager engineering medical devices

작업 내용

Description

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

The hardware engineering manager

• Is accountable for resource and competence management within the OMPS platform hardware team;

• facilitates the translation of technical topics to the 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 quality management system processes;
• Provides coaching (behavioral and/or technical) to the team;
• Liaises with the Platform Lead in the establishment of a strategic product portfolio and roadmap;
• Liaises with project managers to facilitate project execution;
• Liaises with the 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 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: 1) ISO13485 Medical devices Quality management systems Requirements for regulatory purposes, 2) FDA 21 CFR 820.30 Design Controls: design planning, input, output, verification, validation, transfer, review, change and risk management, 3) ISO14971 Medical devices Application of risk management to medical devices, 4) IVDR In Vitro Diagnostics Regulation
• Languages : English: professional working proficiency both spoken and written, Dutch is an asset.

Our offer

Full-time contract. (Freelance also possible)

You will be part of a growing Belgian SME where initiative and personal development are encouraged. We will provide you with an enjoyable work environment with fun colleagues. Well work out a career plan with you, with attention and a budget for extra education/certification. You can count on an attractive salary, supplemented with extra-legal benefits, including a company car.