Department: Device Development
Location: invoX Remote (UK)
Description
The invoX Belgium NV, Respiratory Innovation Centre is focused on the development of pharmaceutical products with superior delivery to the lung using the differentiated technology in our next generation Soft Mist Inhalation (SMI) device. Our proprietary, propellant-free, purely mechanical device delivers medication to the lungs more effectively than other types of inhalers and is poised to change the treatment paradigm in large markets including asthma and COPD.
Central to this activity is the position of Chief Engineer – the overall design authority for the product architecture – the subject matter expert for the design, development and industrialisation of all invoX drug delivery devices. Key is the ability to operate/lead from first principle mechanical engineering tools and techniques. Robust design methodology at the heart of their expertise. For example, comfortably operating within one or more of ICH Quality By Design, LEAN six sigma or systems engineering process, tools and techniques. Being detailed, structured and process driven and many years experience with industrialising medical products. Having a disciplined approach to requirements & risk management, led by requirements, driven by data.
invoX is a research-driven global biopharmaceutical company using next-generation technology platforms to discover and develop innovative medicines that can change the lives of people around the world. Our vision is to be a leading global biopharmaceutical company with an advancing pipeline of products addressing the unmet healthcare needs of patients. invoX is a wholly owned subsidiary of Sino Biopharmaceutical Limited, a Hong Kong listed global top 40 pharmaceutical company with more than 24,000 employees.
Key Responsibilities
In this role, you will be responsible for leading the SMI product in all aspects - technology, design, development and industrialisation. Working with the research team, you will further the development of the SMI platform – looking for innovative solutions to meet business, technical and customer needs. Working with the development team you will outline and agree the product requirement, aligning the concepts and designs to meet these needs and ensure the product is design verified and validated in line with the cost, volume and quality target for industrialisation.
You will be the:
* Overall design authority for invoX respiratory products; owner of the product requirements, associated design intent, models and design history
* System architect for soft mist technology and associated mechanisms
* Co-owner of the drug-2-device interface with the Research team
* Collaborator with the head of Manufacturing Science and Technology (MSAT) to ensure products are designed for manufacturing volume, cost & quality targets
* Materials expert (polymers, metals, elastomers)
* Custodian of essential design space. Ability to build or interpret device-related models (e.g. forces, pressures, springs, fluid path flows, permeation) and correlate them to real-world capability
* CAD/CAE expert including FEA, tolerance stack tools and statistical product and process variance analysis
* Owner of the invoX Respiratory product device roadmap; the technical solutions to business needs
Skills, Knowledge & Expertise
You will have significant experience owning the design and development of a safety critical product.
Essential Technical Skills
* Master in Mechanical Engineering or equivalent medical device related degree
* Good understanding of medical device standards and essential requirements
* Hands on with a robust design process. Preferably ICH QbD related to CFR820 design controls
* Hands on risk management. Experienced with design product DFMEA tools.
* Hands on design for manufacture tools and techniques. Experienced with aligning the product DFMEA to process PFMEA tools.
* Hands on CAD/CAE, (Creo preferable), tolerance stack analysis & statistical tools (Jmp preferred)
* Materials expert. Medical grade plastics, springs and elastomers preferred
Essential Soft Skills
* Good understanding of the English language, both written and spoken
* Comfortable working in different cultures
* Flexible with a can-do and hands-on mentality.
* Self-starter with the ability to work autonomously.
* Excellent problem-solving skills.
* Good planning and organization skills
Desirable
* Track record with patent filing and/or patent management
* Detailed understanding of respiratory standards and regulatory requirements
* Experience with complex respiratory devices
#J-18808-Ljbffr