Biochip Platform Developer

We are seeking a Biochip Platform Developer to participate in the overall development, implementation, maintenance and extension of 1DROP's microfluidics platform. The candidate will join a multi-disciplinary team dedicated to developing high-quality products. The ideal candidate is a team player, likes overcoming difficult challenges, enjoys learning new skills, and has a "hands-on" problem solving approach. This is an outstanding opportunity for a self-motivated individual to make a key contribution and increase their responsibilities in a high-growth start-up environment.

Job responsibilities:

• Investigating and solving the current challenges related to the industrialization of the microfluidics platform
• Planning and analysing scenarios to characterize and improve the performance of 1DROP's microfluidics platform, taking into account current constrains
• Organizing timelines and taking responsibility for the platform development according to milestones and deadlines
• Synchronizing with reader development and assay development to optimize manufacturability and to minimize design transfer time
• Communicating results and progress to 1DROP's team
• Ensuring the rigorous implementation of the processes as per established procedures (SOPs) defined in the Quality Management System (QMS)
• Contributing to the Technical Documentation with specifications, protocols, test scenarios and project reports, etc. and building up a Design History documenting all phases of the biochip platform development.
• Following the market, the industry and 1DROP's competitors, to investigate and evaluate novel or alternative technologies with potential benefits for the microfluidics platform, maximising product value and in alignment with 1DROP's product and business strategy
• Implementing laboratory best practices and ensuring compliance to the applicable General Safety and Performance Requirements (GSPR) list according to the In Vitro Diagnostic Medical Device Regulation (IVDR) with focus on microfluidics platform
• Interacting, assisting and advising purchasing decisions

Required competences for the position:

• Master's or PhD degree in mechanical, chemical or biomedical engineering or similar field, preferably with a focus towards microfluidics technologies for biosensing
• 5+ years success record in microfluidics platform development, preferably in the medical technology industry
• Advanced understanding of production requirements for device manufacturability and associated processes
• Excellent project management skills and experienced in reporting on key microfluidics platform metrics
• Strong ability to transfer microfluidic concepts with differentiated advantages over on-market competitor products into a viable product
• Demonstrated in-depth knowledge working with many analytical & diagnostic instrumentations such as microfluidics, fluorescence imaging systems, photo-spectrometer and processes such as homogenous assay engineering or surface coating
• Knowledge and experience working in a biochemistry laboratory with hazardous chemicals and biological samples
• Ability to act decisively with strong negotiation skills to obtain materials within budget and on schedule and solve staff or equipment-related issues
• Experienced in microfluidic design using AutoCAD, Solidworks, Rhino, or similar
• Knowledge with image processing, statistical analysis and experimental planning, such as design of experiment, process design, characterization, and optimization and associated tools such as ImageJ, R, Python
• Ability to work in a regulated environment with design control and compliance to ISO 13485, FDA cGMP, IVDR 2017/746
• Independent and self-driven to improve processes and achieve targets
• Analytical and structured workflow with attention to detail to ensure high levels of quality
• Excellent English written and verbal communication and presentation skills and ability to communicate with all levels of the organization
• Highly creative and inventive problem solver with a 'hands-on' personality and a can-do attitude
• Calm under pressure, can thrive in a high-volume, continuously changing, fast-paced environment
• Demonstrating flexibility and openness to execute tasks beyond the job description