Senior Engineer, Design Assurance

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At Sonova, we envision a world where everyone can enjoy the delight of hearing. This vision inspires us and fuels our commitment to developing innovative solutions that improve hearing health and human connection - from personal audio devices and wireless communication systems to hearing aids and cochlear implants. We're dedicated to providing outstanding customer experiences through our global audiological care services, ensuring that everyone has the opportunity to engage fully with the world around them.

Guided by a culture of continuous improvement that fosters resilience and self-motivation, our team is united by a shared commitment to excellence and a deep sense of pride in our work, each of us playing a vital role in creating meaningful change,

Here you’ll find a diverse range of opportunities that span both consumer and medical solutions and the freedom to shape your career while making an impact on the lives of others. Join us in our mission to create a more connected world, where every voice is heard and every story matters.

163886

The Senior Design Assurance Engineer is responsible for compliance to procedures and regulations for Design Control of Software, Firmware and Hardware associated with Cochlear Implant Technology. Works collaboratively as the DA representative within a multidisciplinary product development team to ensure the design intent of products is realized effectively and efficiently, including compliance with 21

CFR
820, ISO
13485, ISO 14971, IEC 60601, MDSAP and MDR.

• Manages all Design Assurance aspects of multiple related projects to ensure the overall program is aligned to and directly supports the achievement of strategic objectives (schedule, budget, quality, resources)
• Leads simulation of design concepts under expected and worst case use conditions
• Communicates project progress, risks, issues and mitigations across and up the organization
• Identifies, interprets and provides expertise to the organization on the implementation of international standards (ISO 14971, IEC 60601-1, ISO 13485, particular standards, etc.)
• Ensures designs can meet product specifications, regulatory requirements, and international safety standards such as IEC 60601-1
• Responsible for testing strategy and execution, including feasibility, DV&V, human factors, usability engineering etc.
• Identifies and leads process improvements to ensure consistent implementation of internal requirements and external regulations and standards.
• As needed, participates in or leads the investigations and analysis of product changes and CAPA’s.
• Prepares documentation for and support regulatory submissions (USA, EU, International)
• Creates and delivers training to ensure compliance of medical devices per international standards
• Mentors, trains and otherwise provides guidance to newer or less experienced team members, leveraging product skills and experience

• Bachelor’s degree in Engineering or a related technical discipline required, with training in Design for Manufacturability, Design for Six Sigma, and Lean principles; graduate degree in Engineering, ASQ certification, or related advanced technical education preferred.
• Minimum 8 years of product development and/or design assurance experience, including at least 5 years supporting Class III medical devices, with demonstrated success applying Quality Management principles throughout the product lifecycle and hands‑on engineering testing experience.
• Strong knowledge and application of U.S. and international medical device regulations and quality systems, including 21 CFR 807, 803, 806, and 820, EU MDR, MDSAP, and experience working directly with regulatory agencies such as FDA, PMDA, MHLW, and…