Head of Product Development

hace 6 meses

Barcelona, España Luka Global Group A tiempo completo

**Job Information**:
Industry
- Medical DevicesCity
- BarcelonaProvince
- Barcelona (Barcelona)Country
- SpainPostal Code
- 08001A Head of Product Development is sought to join an established start-up at the forefront of innovation in the international MedTech Sector.

Working on one of the hottest and most relevant topics of today - Women's Health and premature birth the Head of Product Development will lead the development and execution of a Class III/PMA (FDA Regulation) & Class IIb (MDR) Clinical Diagnostic Platform strategy for innovative healthcare technology.

Your responsibilities will include defining product requirements and scope, as well as driving the product development process from concept to launch. With a background in active medical devices (medical devices with electrical components), you will be well-equipped to contribute to the success of the company.

The role can be based in either Barcelona or Bilbao.

**Key responsibilities**
- _
- _Develop system architectures, and describe functions, interfaces, requirements, and risks during product development projects to establish files for hardware and software _
- Partner with project management as technical lead
- Actively design and maintain an efficient effective requirements and product risk management process_ _
- Control implementation of system architecture requirements during product development, and product lifetime
- Train and moderate requirements, risk management sessions and design reviews
- Work closely and build effective relations with key contacts, communicate effectively with internal and external parties (users, suppliers)
- _ Maintain compliance with QSR and ISO regulations and procedures_
- Ensure data accuracy and complete, consistent documentation

**Requirements**:

- Bachelor’s degree or higher in scientific, engineering or medical technology disciplines
- _ E_xperience_ _in system architecture, requirements and risk management for software and hardware products of Medical Devices
- _ E_x_perience with active medical devices (medical devices with electrical components) and_ _of working_ _under-regulated product development with very high safety requirements
- _ Experience_ _in the development of class II or III active medical devices (ideally you_ _will _have placed Medical Devices into the USA/Europe market in a similar role already_ _
- Knowledge of MDR/FDA regulations and standards (ISO13485, ISO14971)

**Benefits**:

- A democratic team culture that encourages everybody to contribute ideas and acquire new skills
- Flexibility - we’re hiring your skills and experience, so we ask you to use these in the most effective way
- Salary in accordance with your profile and experience. Additional benefits including Phantom Shares plan.

By joining this international business, you will have the chance to make a difference becoming part of a project that will impact the lives and health of millions of pregnant women and newborns around the globe.

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