GN Poland
Design Controller
In the role as Design Controller, you will contribute to our purpose of Bringing People Closer. You will plan and implement Design Control deliverables for Medical Device SW projects in compliance with the corporate Quality Management System and regulated standards.
The Team you will be part of
R&D Hearing team in Poland is a part of a global team developing software for Hearing Instruments. We are important contributors of international engineering teams for Cloud and Mobile App, collaborating closely with colleagues in Denmark, US and India. As Design Controller, you will be supporting Cloud and FSW teams.
GN Poland
IT and R&D center in Poland
Full time opportunity
Warsaw / remote
Brain Embassy, Warsaw/Poland
The primary objective of the role is to:
- Plan and coordinate completion of Software Development deliverables in compliance with corporate QMS and IEC 62304
- Facilitate design reviews, participate in risk assessments etc. to ensure compliance
- Work with Corporate Quality and internal stakeholders to streamline, optimize and improve compliance documentation
- Oversee audit processes, including findings from GN Online Services and Fitting Software
- Improve and optimize Design Control process.
Leadership & Development:
- 5+ years in Medical Device Industry
- Proficiency in English
- Solid understanding of Medical Device Design Control and regulations (21 CFR 820.30, ISO 13485, ISO 14971, IEC 62304, IEC 62366, 21 CFR 820.30)
- Demonstrated initiative; results oriented; willingness and ability to institute change
Ability to communicate effectively in a multi-discipline environment, and across cultures and levels of the organization - Proficient verbal and written communication skills; including experience in writing and presentation skills
- BS in Engineering or Sciences.
More information:
FSW (Fitting Software) is an application used to fit Hearing Instruments that interfaces with standalone and cloud-based patient databases. It is a medical device that is part of a larger system including Cloud, Firmware, Mobile App, HW, and Online, with development teams located in the US and India.
The Cloud is a cloud-based solution used for customer and patient related data management, used in combination with the Mobile App and FSW to remotely fit a Hearing Instrument. The development and test team for the Cloud is located in the US, Denmark, Poland, and India.
GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technologies that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts.
GN was founded more than 150 years ago with a vision to connect the world. Today, inspired by our strong heritage, GN touches more lives than ever with our unique expertise and the broadest portfolio of products and services in our history – bringing people closer to what is important to them. We market our solutions with the brands Jabra, ReSound, SteelSeries, Beltone, Interton, BlueParrott, Danavox, and FalCom in 100 countries. Founded in 1869, GN Group employs more than 7,000 people and is listed on Nasdaq Copenhagen (GN.CO). Visit our homepage GN.com and connect with us on LinkedIn, Facebooku and X.