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Manufacturing & Product Development Manager - Medical Device

Company

Our Client is a startup medical device IVD company specialized in Transfusion field. The company was launched in 2016 with a team of dedicated experts both from academic and industry backgrounds.

The Company owns exclusive licenses on two patents submitted, under ongoing review and already approved in most major markets. These 2 patents open high expectations in term of new product pipeline.

The Company is currently completing technical development and clinical validation of its first device to be launched in a high potential Transfusion market segment.

The Company will initiate in 2019 the implementation of its industrialisation strategy.

To succeed in its industrialisation strategy, our Client is looking for a highly motivated Manufacturing & Product Development Manager with an operational background in manufacturing and product development processes required in medical device industry.

Role

As Manufacturing & Product Development Manager, you are in charge of production strategy and new product development.

You are a core member of the management team and accountable for manufacturing KPI’s achievements. Under transitory supervision of external senior industrial designer/engineer, you will be in charge of new product development.

Reporting to the CEO, you are an expert in product development, technology and industrialization with a strong drive to deliver.

Main activities include :

Manufacturing related activities

  • Design/structure of the new manufacturing assembly line for the consumable
  • Coordinate the implementation of the new manufacturing assembly line for the consumable with related selected subcontractors
  • Manage external subcontractors in charge of the assembly of the reusable device
  • Assess (RFQ) and select suppliers in collaboration with relevant internal/external teams
  • Perform technology watch on the market to maintain level of technical expertise
  • Ensure manufacturing outputs, cost and time constraints in line with company objectives and forecasts
  • Identify and mitigate potential issues as soon as possible
  • Identify process improvements
  • Perform risk assessments
  • Ensure support to RA/QA manager for SMQ and ISO13485 compliance and relevant internal and external audits
  • Coach/Support production team for all development/industrialization/ GMP manufacturing activities and, as production front line, support Business team for technical discussion with potential partners

Product development related activities

  • Under supervision of external senior industrial designer/engineer, coordinate development of new consumable design development
  • Coordinate development of new reader design development with external selected subcontractor
  • Involvement in user workshops and in new product pipeline definition

Profile

Civil or Industrial Engineer, master degree or relevant experience in Medical Device (preference) or Life Science industries

  • 5-10 years of MedTech or pharmaceutical/biotech industry experience
  • Expertise in manufacturing environment
  • Experience in SMQ management in ISO Certified environment (minimum ISO9001)
  • Knowledge and experience of ISO13485 SMQ is a plus
  • Experience of medical device design development is a plus
  • Expertise in GMP and Aseptic processing is a plus
  • Knowledge of transfusion, biologics (antibodies/antigens), microfluidics, micro-electronics, micro-injection molding and/or centrifugation fields is a plus
  • Excellent organizational skills and keen attention to detail.
  • Communicates clearly and concisely with diverse audiences, in both oral and written contexts, and is comfortable giving and receiving feedback.
  • Fluent in French and English
  • Rigorous, passionate, autonomous, dynamic and excellent team skills
  • Ability to structure processes, manage project and lead team
  • Hands-on problem solving and proactive attitude
  • Ability to work autonomously in less structured environments
  • First experience in startup with entrepreneurial mindset, is definitively a plus
  • Resilience; calm and deliberate under conditions of stress
  • Open mind, enthusiastic, sense of innovation and literature reading and update.

Offer

. Innovative startup environment in a dynamic and professional team

. Various and stimulating challenges

. Direct operational responsibilities

. Involvement in company strategic decisions with CEO

. Attractive package aligned with your expertise

Publication date

08.05.2019

Contact person

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