Principal Manufacturing Engineer (Instrument & Console) Job in Mechelen, Belgium

Biocartis is a privately owned biotech company that engages in the development of novel diagnostics technology platforms for low to highly multiplexed detection of molecular-based biomarkers. Biocartis is based at the EPFL Science Park in Lausanne (Switzerland), at the High Tech Campus in Eindhoven (The Netherlands) and is setting up a manufacturing and assay development facility in Mechelen (Belgium).

Principal Manufacturing Engineer (Instrument & Console) Job Description

Principal Manufacturing Engineer (Instrument & Console)

To lead the manufacturing engineering function at Biocartis, with responsibilities for the industrialization, design transfer, and production processes of the Instrument and Console assembly. Post product launch, to take responsibility for the day–to-day Instrument and Console manufacturing activities within the Mechelen facility ensuring production build schedules are met. Ensuring the manufacturing facility is fully compliant with the requirements of the Biocartis QMS with regards to FDA / CE requirements for In-Vitro Diagnostic (IVD) medical device regulations and EN14001 environmental management.

Tasks/outcome domains
To support the transfer of industrialised instrument manufacturing from the major development sub-contractor to Biocartis. Includes, but not limited to: 

- Confirming that the assembly lines are fit for purpose prior to transfer to Biocartis; 
- Overseeing the design, manufacture and validation of assembly line equipment (IQ, OQ, PQ), tooling, jigs and fixtures used in-house and at supplier’s premises. 
- Ensuring all measuring equipment used on the assembly line is correctly documented, and that records for each piece of equipment are maintained. 
- Ensuring the development of factory acceptance test equipment, Quality Control (QC) test and release procedures, and the verification and validation of QC software are undertaken in accordance with the Quality Management System requirements. 
- Ensuring that material and components are fully verified prior to transfer. 
- Line management of direct and indirect operations staff. 
- Participating in Supplier Technical Reviews. 
- Ensuring all documentation is prepared in accordance with Quality Management System requirements including BoMs, Engineering Change Orders, assembly instructions, process Failure Modes and Effects Analysis (pFMEAs), assembly procedures, Device Master Record, and Device History Records. 
- Providing manufacturing related input (DFM, DFT, DFA, Poka-Yoke etc) into new product developments. 
- Contributing to product and process improvements, including supporting the resolution of customer complaints, quality improvement, cost down initiatives, and supply chain vendor management. 
- Raising, implementing, closure of ECOs relating to manufacturing processes.
- Contributing any root cause analysis investigations of returned customer instruments in conjunction with the QA/RA team. 
- Contributing to the materials review processes for disposition of rejected or scrapped parts through the Non-Conforming Materials processes. 
- Implementation of lean and six sigma best practices for the optimisation of manufacturing processes and methods.
- To support the senior management team in the identification, short-listing and selection of suitable contract manufacturing partners for the long term supply of components, sub-assemblies, or finished units. 
- To oversee the day to day manufacturing operations ensuring production build schedules are maintained. 
- Preparing production metrics and reports for senior management review.
- Training of assembly line staff and operators on processes and procedures.
- Ensuring compliance with the Biocartis Quality Management System at all times.

Principal Manufacturing Engineer (Instrument & Console) Job Requirements

• A Degree in Production / Manufacturing Engineering or equivalent technical discipline.
• At least five years’ experience working in a manufacturing organization producing medical devices, pharmaceuticals or in-vitro diagnostic equipment working within an ISO 13485 / GMP compliant environment.
• Lean or six-sigma manufacturing techniques.
• Experience of manufacturing or assembling complex electro-mechanical / optical devices.
• Worked within new Product Development Teams on the industrialization, transfer to manufacturing and production ramp up of new products.
• Working alongside a Contract Manufacturing Organization (CMO).
• Advanced knowledge, orally and in writing of Dutch and English.
• MS Office, data analysis / statistical analysis packages, advanced data analysis spread sheets, production test software.

Competencies: Time management Accuracy, Achievement, Results Focused, Communication, Decision making, Developing others, Customer Satisfaction.

Principal Manufacturing Engineer (Instrument & Console) Application Information

Please apply with your CV and Motivation letter  by the 'apply' button below.

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 shape your job. Your input is highly appreciated. Of course we offer you a fitting compensation package.

Principal Manufacturing Engineer (Instrument & Console) Summary

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