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.
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
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.
. 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