As our Mechanical Engineer you will be working in the hardware engineering team responsible for the development of the miDiagnostics point of care diagnostic reader and disposable card.
You will have experience leading technical projects and you will understand how to navigate the technical complexities to design and develop point of care and lab-based systems and guide multi-disciplinary teams to ensure the product meets the requirements.
- Designing, prototyping and enhancing mechanical systems and devices.
- Working closely with miDiagnostics partners and suppliers to design and develop engineering test rigs at part and subsystem level.
- Conducting research, documenting findings, and presenting reports at meetings.
- Developing design documents for mechanical parts and final products.
- Identifying areas of weakness in the planned products and making recommendations for improvement.
- Selecting the required tools and materials for the manufacturing process.
- Master’s degree with 3- 5 years of experience in Mechanical Engineering, Applied Science or Bioengineering (with strong background in mechanical design and manufacturing) required
- Track record of executing medical device development projects, taking responsibility for quality, time and costs
- Creative and technical in many of the following areas: concept generation; engineering and statistical analysis; detail design; design of experiments; design for high and low volume manufacturing.
- Technical awareness gained in one of the following environments: engineering department of a medical or pharmaceutical company; technical or design consultancy; technology start-up.
- Current hands-on expertise in areas such as: concept generation; engineering analysis and detail design; 3D CAD; prototyping and lab testing; design for high and low volume manufacture; design for high reliability; transfer to manufacture; manufacturing process development; world class manufacturing principles
- A drive to rapidly absorb and develop further technical and project skills
- Ambitions to learn and develop further technical and team skills
- Confident when presenting ideas and results
- Familiar with working to ISO standards for design control; compilation of Design History File; verification and validation
- An excellent knowledge of English is a must (spoken and written); Knowledge of Dutch is an asset.
- You feel comfortable in a start-up environment and you can easily switch from one task to another
- You appreciate working in an open space amongst enthusiastic, multidisciplinary and international colleagues
- It is essential that you hold entitlement to work and live in Belgium
Ideal candidate requirements:
- Experienced in designing systems that implement complex biochemical assays and able to navigate the technical and cost trade-offs to develop balanced products.
- Career in diagnostic device development, ideally having been involved in a product development and launch
- Experience working with remote teams.
- Highly creative and highly technical in many of the following areas: concept generation; engineering and statistical analysis and detail design; design of experiments; design for high and low volume manufacturing
- Project leadership skills to drive a team’s development efficiently and effectively towards end goals.
- Practical experience of healthcare industry-specific regulatory processes: working to Quality Management Systems such as ISO 13485/ISO14971; design control; compilation of Design History File; verification and validation; clinical trial support
- Experience with process development and manufacturing realisation activities such as DFMA, pFMEA and QC plan, process validation
- Current hands-on expertise in areas such as: design for high reliability; transfer to manufacture; manufacturing process development; world class manufacturing principles