Specialist (m/f/d) on Basic Safety and Essential Performance

Formed in 2019, through the merger of Sivantos and Widex, WS Audiology combines over 140 years’ experience in pioneering the use of technology to help people with hearing loss hear the sounds that make life wonderful. We are active in over 125 markets and employ 11,000 people worldwide. Our broad portfolio of hearing related products and services generates annual revenues of around EUR 1.7 billion.

Learn about us on www.wsa.com   

 

The Team

This team is part of R&D. System engineering is taking care about high level requirements and concepts considering dependencies of building blocks. This guidance is the input to many departments such as Signal Processing, ASIC, HW, Firmware, Fitting Software, etc.

By its nature, it’s addressing system complexity, performance and interoperability.

 

The Role

A crucial consideration of the overall as well as sub level systems is Basic Safety and Essential Performance.

In this role you will have the following responsibilities:

  • Global owner of Basic Safety and Essential Performance
  • Drive harmonization within WSA (ex- Sivantos, ex-Widex) to comply with IEC 60601-2-66 (particular standard for hearing aids based on IEC 60601-1)
  • Update concept and process of Basic Safety and Essential Performance
  • Maintain work instruction and templates
  • Continuous follow up with Regulatory Affairs
  • Continuous follow up with homologation managers in terms of required certificates
  • Translate standard into product requirements
  • Provide support to product development


Requirements

We expect you to have fundamental experience in the field of (Basic Safety) Quality Management. Ideally, you have some know-how how to handle medical products according to applicable standards, already.

You are a team player, who can drive topics but seeks feedback and engage in constructive discussions with your colleagues. Creativity, attention to detail, and a collaborative attitude are part of your strengths.

You most likely fit the following profile:

  • completed university degree in engineering
  • minimum three years of work experience in a relevant field
  • pragmatic nature and focus on efficient implementations
  • keen on networking
  • well-founded English skills

 

Join WS Audiology

Please submit your CV as soon as possible. We will screen and invite candidates for interviews on an ongoing basis.

We usually respond within two weeks

Or, know someone who would be a perfect fit? Let them know!

Erlangen

Henri-Dunant-Straße 100
91058 Erlangen Directions View page

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