Head of Product Development
Head of Product Development - System Architect
A Product Developer / System Architect is sought to join anestablished start-up atthe forefront of innovation in the international MedTech Sector.
Working on one of the hottest and most relevant topicsof today – Women's Health and premature birth the Head of Product Development will lead thedevelopment and execution of a Class III/PMA (FDA Regulation) & Class IIb(MDR) Clinical Diagnostic Platform strategy for innovative healthcaretechnology.
Your responsibilitieswill include defining product requirements and scope, as well as driving theproduct development process from concept to launch. With a background in activemedical devices (medical devices with electrical components), you will bewell-equipped to contribute to the success of the company.
The role can be based in either Barcelona or Bilbao.
Key responsibilities
- Develop systemarchitectures, and describe functions, interfaces, requirements, and risksduring product development projects to establish files for hardware andsoftware
- Partner with projectmanagement as technical lead
- Actively design and maintainan efficient effective requirements and product risk management process
- Control implementation ofsystem architecture requirements during product development, and product lifetime
- Train and moderaterequirements, risk management sessions and design reviews
- Work closely and build effectiverelations with key contacts, communicate effectively with internal and externalparties (users, suppliers)
- Maintaincompliance with QSR and ISO regulations and procedures
- Ensure data accuracy andcomplete, consistent documentation
Requirements
- Bachelor’s degree or higher in scientific, engineering ormedical technology disciplines
- E xperiencein system architecture, requirements and risk management for software and hardware products of MedicalDevices
- E xperience with active medical devices (medical deviceswith electrical components) and of working under-regulated product developmentwith very high safety requirements
- Experience in the development of class II orIII active medical devices (ideally you will have placed Medical Devices into theUSA/Europe market in a similar role already
- Knowledge of MDR/FDA regulations and standards (ISO13485, ISO14971)
- Ademocratic team culture that encourages everybody to contribute ideas andacquire new skills
- Flexibility– we’re hiring your skills and experience, so we ask you to use these in themost effective way
- Salaryin accordance with your profile and experience. Additional benefits including PhantomShares plan.
Byjoining this international business, you will have the chance to make a differencebecoming part of a project that will impact the lives and health of millions ofpregnant women and newborns around the globe.
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