Design Controller
2 months ago
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.
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.
Your contribution is appreciated, and you will:
- 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.
To succeed in the role, we imagine that you:
- 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.
We encourage you to apply
Even if you don’t match all the above-mentioned skills, we gladly receive your application if you think you have transferrable skills. We highly value the right mindset; motivation and energy and we believe that the right personal competencies are highly important for creating growth.
We are committed to an inclusive recruitment process and all applicants will receive equal consideration for employment.
Join us in bringing people closer
GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technology that enhance the senses of hearing and sight. We enable people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experience for audio and gaming enthusiasts.
The GN culture
GN’s values listen, challenge and transform form our culture. We greet every day with energy, engagement, and enthusiasm, bringing our best selves and approaching problem-solving and challenges with a ‘glass half full’ attitude. We’re independent, but we also know when two heads are better than one.
Our leaders are friendly, our teams are tight-knit, and we believe in the power of collaboration across every level of our organization.
The company's offerings include multiple benefits and flexibility that bolster our well-being and aid us in aligning our focus with what is personally and professionally important.
We hope you are curious to explore and engage in the recruitment process with us.
#LI-GNGroup
Location: Brain Embassy, Warsaw
Additional location:
- Home Office (Poland)
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