Head of Product Development System Architect

Innitius is seeking a highly skilled and strategic Head of Product Development (System Architect) to join our Product Development team.

In this role you will have the opportunity to lead the development and execution of our Class III/PMA (FDA Regulation) & Class IIb (MDR) Clinical Diagnostic Platform strategy for our 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 focus or background in healthcare you will be wellequipped to bring a valuable perspective to this role and contribute to the success of our company.

If you have a passion for driving product innovation in the MedTech industry we encourage you to apply for this exciting opportunity.

About INNITIUS: We are at the forefront of innovation in the international MedTech Sector working on one of the hottest and most relevant topics of today Womens Health and premature birth. By joining our team in whatever role you will get to make a true impact on the lives of others. Recently funded by the EIC Accelerator and leading Healthtech Investors as Clave Capital and Nara Health Capital you will be part of a project that will impact the lives and health of millions of Pregnant women and newborns around the globe!

Tasks

The positions role is:

• to own the product technology landscape
• to develop system/ software architectures and requirements for products and
• to manage their risk files accordingly over the whole product life cycle.

You will further develop and maintain our requirements and risk management process in order to achieve conformity with applicable quality standards.

Strong leadership skills are necessary to drive architectural and risk management tasks and to coordinate the applicable stakeholders ( eg management and SMEs internal and external different company functions)

High engineering acumen and deep analytical and structural thinking are required to develop the system architecture along industry standards.

Requirements

• 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 and 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 at all times.
• Coordinate with internal/ external parties and stakeholder in a crossfunctional team.
• Ensure data accuracy and complete consistent documentation at all times.
• Cover all needed activities via an adequate project management planning and reporting.

Leadership Profile:

• Due to the nature of the targeted process area you must have a relentless positive approach and can do attitude.
• Excellent communicator
• Approachable
• Patient
• Enthusiastic and able to motivate staff.
• Able to influence and persuade.
• Highly organized methodical with strong people skills able to adapt to the audience.

Education and Knowledge profile:

• Bachelors and masters degree in medical technology engineering sciences or similar
• experience in system architecture requirements and risk management for software and hardware products of Medical Devices
• experience with active medical devices (medical devices with electrical components) and worked underregulated product development with very high safety requirements
• experience in using requirements tools
• experience in the development of class II or III active medical devices (E2E ideally you have placed 2 to 5 Medical Devices into the USA/Europe market in a similar role already
• knowledge of FDA/ MDR regulations and standards (e.g. ISO13485 QSR ISO14971)
• fluent English

Benefits

Aside from this we provide all the necessary support and perks to make your life at work and outside of work fun and comfortable all year round such as:

• Flexibility were hiring your skills and experience so we ask you to use these in the most effective way. At the moment we are working from the offices (Bilbao and Barcelona) however we are comfortable offering remote work as well.
• A democratic team culture that encourages everybody to contribute ideas and acquire new skills we have regular catchups as a global team and have the opportunity to work crossfunctionally as needed.
• The person who joins the company will be able to develop his or her professional career within a rapidly expanding Startup.
• Salary in accordance with your profile and experience.
• Additional benefits (Stock options / Phantom Shares plan) can be evaluated.