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Production Manager - MedTech start up

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

About us

BluSense Diagnostics is an innovative start up in the MedTech business! We work hard to become 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.

The job

We are looking for a Production Manager who can lead the BluSense ViroTrack cartridges manufacturing activities. Your job will be to focus on leading and expanding the production team, improving efficiency and ensuring 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 molding processes.

As Production manager you will ensure a 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.

Your 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 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 by 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 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 mind-set 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 not later than June 22th, by sending us your CV and a cover letter via "Apply now".

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

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

Apply online Gem job

Arbejdssted

Copenhagen

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