BluSense Diagnostics is an innovative start up in the MedTech business. We work hard to become a global leader within the Infectious disease point-of-care diagnostics. We combine complex scientific areas such as nanotechnology, biochemistry, optics, and hardware and software engineering in developing the next generation of point-of-care testing for infectious diseases.

We are looking for a highly competent and ambitious Production Manager who can lead our production of next-generation diagnostic devices for infectious diseases.

The position
Your job will focus on leading and expanding the production team, improving efficiency and ensuring the quality of multiple products manufactured on a pilot production line. You will be responsible for scaling-up the current manufacturing capacity through the installation of a brand-new manufacturing line able to cope with high volume throughput.

As an ideal candidate, you will have in-depth knowledge about high-throughput manufacturing lines, quality controls, process development and validation, microfluidics assembly, biochemistry and reagents quality control, medical device regulations and standards (such as IVDD and ISO 13485:2016), automation, and ideally in injection moulding processes.

As Production Manager, you will ensure close collaboration with the Biochemistry department (production section), sales and marketing department and the R&D department (design transfer phase of new product lines and processes). Furthermore, you will ensure that the production follows our quality management system and support RA/QA functions when needed.

Responsibilities
•    Supervision and technical coordination for the overall planning, execution and documentation of the manufacturing of microfluidics consumables at BluSense Diagnostics.
•    Ensure that production processes (including non-conformities and changes) and production equipment are developed, monitored, maintained and documented according to BluSenses quality management system.
•    Ensure that Manufacturing batch records and other documentation are prepared, completed and stored according to the company QMS
•    Responsible for warehousing and shipping of ViroTrack cartridges and BluBoxes.
•    Ensure that all components needed for the manufacturing of ViroTrack products are available.
•    Responsible for interfacing and building strong relationships with key suppliers.
•    Assist with Manufacturing investigations, CAPA actions and other process equipment related quality concerns
•    Collaborate closely with R&D to ensure the efficient transfer to production of novel microfluidic products to manufacturing. 
•    Responsible for managing and maintaining all safety and environmental standards and operating the areas of responsibility within quality, delivery, cost and profit objectives.
•    Motivate, inspire and promote self-growth and internal development within the team. Lead and promote continuous improvement through team and individual initiatives.
•    Lead a production team of currently 6 members. 

Your qualifications
•    You are an ambitious candidate who has an excellent track record of achievements and broad experience in dealing with medical device production processes and related quality standards and procedures.
•    Knowledge of Design Control and technical documentation structure for medical devices. Experience in IVD/microfluidic-based devices is a strong plus.
•    Proven ability to lead a team composed of production operators and process engineers.
•    Interest, ambition and ideally experience of working in a similar, small company environment (about 50 employees).
•    Basic knowledge of budgeting, cost analysis, manpower planning, training, project management.
•    Minimum of 3 years of relevant work experience within the leadership of manufacturing lines in medical devices and/or other regulated environments.
•    English on negotiation level. Knowledge of Mandarin is a plus.

Personal skills
•    Excellent analytical skills and problem-solving capabilities to determine risk assessment.
•    Strong drive and willingness to walk the extra mile.
•    High degree of dynamic and pro-actively mindset willing to show the direction.
•    High degree of comfort in working with a young and multi-cultural team.
•    Ability to work in a fast-paced start-up environment.

We offer
•    A challenging and fast-growing working environment with strong Danish-Taiwanese cooperation.
•    Co-operation and exchange of ideas within a multinational company.
•    Professional and personal development in scaling a high-MedTech international company.
•    Competitive compensation and benefits.

How to apply
Please apply as soon as possible but no later than June 22th, by sending us your CV and a short text file via www.thehub.dk.

We plan to hire for a job start in June/July 2019.

If you have any questions, please contact the hiring manager, Chief Scientific Office: Marco Donolato at marco@blusense-diagnostics.com.