Inicare careers

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the frontiers of medical science
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Currently open positions

Senior Software Developer

For our innovative startup company located in Eindhoven, The Netherlands we have an opening for a Senior Software Developer.

About the position
For our development team we are looking for an energetic medical software expert to drive the development of our prototype software. You will be based in Eindhoven, but as you will work closely with our development partner in FR Macedonia frequent travel to the city of Stip (FRM) and some international travel will be required.

You do have
– solid understanding of the concepts of object oriented programming and event driven programming
– solid background in the development cycle, including design specifications, prototyping, coding patterns, interface development and testing
– experience with mobile app development, basic knowledge in BLE protocol, mathematical and signal processing aptitude
– experience on building REST API & Web sockets
– knowledge of SQL and NoSQL databases
– experience with machine learning using hardware generated data

You are
– a team player, however very well capable of working independently
– capable of working within strict deadlines in a high pressure, challenging international environment
– a self-starter, comfortable in a DIY startup environment
– very familiar with the medical industry and its regulations
– able to represent Inicare at events

We are not looking for
– contractors
– acquisition from recruitment agencies

About Inicare Life Science & Technology
Inicare develops health and life science technology to healthcare consumers and professionals around the world.
Inicare solutions leverage on innovative and proprietary technologies to commercialize wearable and discrete vital signs monitoring devices for use at home or in the clinic.

While in western society people grow older than ever before, many develop multiple conditions during their lifetime for which they seek medical assistance.
This causes an increasing strain on medical professionals which ultimately reduces the availability of healthcare: an increasing number of patients do not receive timely medical aid.
Medical science and technology however is evolving rapidly, not only creating new treatment opportunities but also empowering both patients and professionals to change current medical practice.
Our mission is to provide clinically validated solutions to both patients and professionals to cope with day to day healthcare diagnostics.

For more information about the position please contact Mr. Maarten Meelkop, Managing Director at careers@inicare.com or visit our website at www.inicare.com.

Quality Manager

We are looking for a Quality specialist, experienced in the field of Medical Devices, to join our company and fulfill the role of Quality Manager. There is opportunity to grow into the role of QA/RA Manager.

· Assure the quality and safety of innovative medical products by implementing a full Quality Management System (QMS) suitable for medical device development, starting with a light-weight framework and expanding it over time.
· Provide the Quality corner stones that are required to support regulatory submissions of our products to both Notified Bodies and the FDA.

Responsibilities:
· Implement a Quality Management System, in conformance with FDA and ISO 13485:2016 Design Controls, through the integration of internal and external/medical device industry best practices.
· Measuring Key Performance Indicators. This includes defining, measuring, analyzing KPIs, used in product and process improvement.
· Review & Approval Activities. This includes design verification and validation documentation.
· Inspection & Acceptance Activities. This includes acceptance of supplier deliverables.
· Risk Manager. Lead and participate in risk management sessions.
· Training Coordinator. Coordination, administration and evaluation of training for xxxx personnel.
· Design Controls. Guide the product development process and associated verification and validation activities.
· Document Controls. Supporting role for document control in product development.

Qualifications:
· A completed university degree.
· A minimum of 5 years of full-time ‘hands-on’ work experience in the field of medical devices or related sectors (e.g. medical industry, healthcare, audit or research) including at least 3 years of Quality experience e.g. working within a certified QMS such as ISO 13485 and FDA.
· Fluency with (new) EU directives/regulation, guidelines and FDA regulations;
· Demonstrable experience in writing Quality Policies and Procedures and composing technical files/regulatory dossiers suitable for regulatory submissions.
· Confident, able to communicate and collaborate with all levels within the company;
· Able to assimilate, articulate and present information at a high level;
· Excellent interpersonal skills as well as strong verbal communication and report writing skills.

We are not looking for
– acquisition from recruitment agencies

About Inicare Life Science & Technology
Inicare develops health and life science technology to healthcare consumers and professionals around the world.
Inicare solutions leverage on innovative and proprietary technologies to commercialize wearable and discrete vital signs monitoring devices for use at home or in the clinic.

While in western society people grow older than ever before, many develop multiple conditions during their lifetime for which they seek medical assistance.
This causes an increasing strain on medical professionals which ultimately reduces the availability of healthcare: an increasing number of patients do not receive timely medical aid.
Medical science and technology however is evolving rapidly, not only creating new treatment opportunities but also empowering both patients and professionals to change current medical practice.
Our mission is to provide clinically validated solutions to both patients and professionals to cope with day to day healthcare diagnostics.

For more information about the position please contact Mr. Maarten Meelkop, Managing Director at careers@inicare.com or visit our website at www.inicare.com.

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