Are you ready to work in a rapidly growing Biotech start-up? Helping out with your initiative and your problem-solving attitude? We are looking for you to join our great team!

About us

BluSense Diagnostics is an award-winning, innovative start-up in the med-tech business, working hard to become the global leader within infectious point-of-care diagnostics. We combine complex scientific areas such as nanotechnology, molecular biology, biochemistry, optics, hardware and software engineering in developing the next generation of point-of-care testing for infectious diseases such as dengue fever which affects over 390 million human beings each year! Please visit our website to learn more: www.blusense-diagnostics.com.

We are a highly motivated team of 50+ employees from 20 nations, with offices in Denmark and Taiwan. We have a clear ambition to retain and develop a great work environment and a strong business performance.

We are currently looking for a quality-mindset Manufacturing Engineer for our Production department to help on improving the production line, setting up maintenance and actively participate in qualification of existing as well as new equipment investments. Do you want to take part in the generation of next-generation diagnostic devices for emerging infectious diseases? Do you thrive in a dynamic and collaborative international working environment? If yes, apply now!

The job

You will take responsibility in the development of a maintenance schedule for existing and new equipment, such as dispensing units, ovens, printers and conveyors. In addition, you will be responsible for authoring and executing equipment qualifications in collaboration with the engineering team and quality team. Additionally, you will be authoring related non-conformities and change requests as well as participating in the execution of corrective and preventive actions. Thus, you will work closely with the engineering, R&D and QA on multiple projects.

Your responsibilities

• Work according to BluSense ISO:13485 quality system.

• Setup maintenance schedule for equipment on the production line as well as for new equipment purchases.

• Author Change Requests, Qualification Protocols, Non-conformities and other production related documentation.   

• Execute Qualification activities for new equipment or existing equipment.

• Develop spare parts inventory and maintain the inventory

• Equipment vendor contact for service requests or spare parts

Your qualifications

You are a highly skilled, dedicated and organized mechanical engineer or technician with high quality standards able to handle multiple tasks at the same time while consistently delivering high-quality results. You work independently with a proactive and positive mindset.

 Background as Mechanical Engineer, Technician or similar.

• Background as Mechanical Engineer, Technician or similar.

• Experience with ISO13485:2016 or GMP.

• Work experience with automated equipment is required.

• Experience with equipment qualification execution and documentation is required.

• Fluent in English both verbal and written.

• Solid computer literacy, including Microsoft Excel and PowerPoint.

• Strong interest in new technologies

Your personal skills

• Ability to organize and conduct your work in a structured manner

• Ability to coordinate between R&D engineering and ISO 13485 requirements

• Able to maintain focus in a fast-paced and dynamic environment

• Excellent interpersonal skills to communicate effectively with colleagues

• Positive attitude with the capacity to be a good team player

• Commitment to the team’s goal of providing outstanding high-quality products

We offer

• Working in a MedTech start up making a difference to a large part of the world’s population.

• Working with cutting-edge bio-assay technology.

• Co-operate and exchange of ideas within a multinational and interdisciplinary team.

• Professional and personal development opportunity in being part of scaling up and optimizing production processes

How to apply

We will process applications and do interviews as they arrive. Therefore, please submit your cover letter and CV in one PDF file as soon as possible, by applying via thehub.dk. Only applications submitted via thehub.dk will be reviewed, so please do not send your CV or applications through mail.

We plan to hire for a job start in March/April 2020.