Senior Engineer, Design Assurance

Sonova Group; California; Hybrid; USD 100,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, vision

401k with company match

Life/AD&D insurance

Disability coverage

Paid time off

Parental leave

Hearing aid discount

Career growth opportunities

TeleHealth

Job summary

Sonova is seeking a Senior Design Assurance Engineer to drive compliance for Software, Firmware and Hardware in Cochlear Implant tech. You’ll partner with a multidisciplinary team to ensure design intent meets 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, MDSAP and MDR standards.

You’ll lead testing strategies, risk assessments, CAPA investigations and regulatory submissions, while mentoring teammates in a fast-paced, matrix environment. Hybrid work model and comprehensive benefits are offered.

Qualifications

• Bachelor’s degree in Engineering or a related technical discipline; advanced training preferred.
• Minimum 8 years in product development/design assurance, incl. 5 years with Class III devices.
• Strong knowledge of U.S. and international medical device regulations and quality systems.
• Experience working with regulatory agencies during audits.

Responsibilities

• Manage design assurance across multiple projects to meet strategic objectives.
• Lead design concept simulations under various conditions.
• Communicate progress, risks and mitigations across organization.
• Provide expertise on ISO/IEC standards and regulations.
• Ensure designs meet specifications and regulatory requirements.
• Plan and execute testing strategies including DV&V and usability.
• Lead CAPA investigations and product change analyses.
• Prepare regulatory submissions and training materials.

Skills

Regulatory knowledge

Cross-functional teamwork

Analytical skills

Problem solving

Documentation proficiency

Communication skills

English proficiency

Education

Bachelor’s degree in Engineering

Graduate degree preferred

Tools

Agile PLM

Minitab

SolidWorks

Microsoft Office

Job description

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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.

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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 21CFR820, ISO13485, ISO 14971, IEC 60601, MDSAP and MDR.

Responsibilities:

• 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

More about you:

• 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 TÜV during and outside of audits.
• Proven ability to work effectively in cross-functional matrix organizations, collaborate with diverse stakeholders, multitask in fast‑paced environments, adapt to changing priorities, and lead through sound judgment and quality-focused decision‑making.
• Excellent analytical, problem‑solving, communication, and technical skills, with the ability to drive results, maintain accountability, apply attention to detail, and communicate effectively both verbally and in writing.
• Broad technical expertise across disciplines such as Mechanical, Electrical, Biomedical and Systems Engineering, Materials Science, Biology, Neurophysiology, and Statistics, with experience in cochlear implants, medical device electromechanical systems, consumer electronics, biomedical restoration technologies, and AI tools such as ChatGPT, Gemini, and Claude considered advantageous.
• Proficiency in English, Microsoft Office, Minitab (or equivalent statistical software), and SolidWorks CAD (or equivalent), with second‑language proficiency, Agile PLM experience, and other product lifecycle management systems considered a plus.

A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova

Don't meet all the criteria? If you’re willing to go allin and learn we'd love to hear from you!

What we offer :

• Medical, dental and vision coverage*
• Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
• TeleHealth options
• 401k plan with company match*
• Company paid life/ad&d insurance
  • Additional supplemental life/ad&d coverage available
• Company paid Short/Long-Term Disability coverage (STD/LTD)
  • STD LTD Buy-ups available
• Accident/Hospital Indemnity coverage
• Legal/ID Theft Assistance
• PTO (or sick and vacation time), floating Diversity Day, & paid holidays*
• Paid parental bonding leave
• Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)
• Robust Internal Career Growth opportunities
• Hearing aid discount for employees and family
• Internal social recognition platform

This role's pay range is between: $100,320/yr -$150,480/yr. This role is also bonus eligible.

How we work:

At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.

Sonova is an equal opportunity employer

We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.