Senior Engineer, Design Assurance

Sonova USA, Inc.; California; Hybrid; USD 100,000 - 150,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k plan with company match

PTO and holidays

Tuition reimbursement

Hearing aid discount

Job summary

Sonova USA, Inc. is seeking a Senior Engineer in Design Assurance to lead QA across projects, ensuring alignment with schedule, budget, and regulatory standards. The role requires extensive testing strategy, cross-functional collaboration, and strong regulatory knowledge.

The candidate will drive compliance with ISO 14971, IEC 60601-1, and 21 CFR parts relevant to class III devices, while mentoring peers and shaping process improvements in a dynamic hybrid work environment in Valencia, CA.

Qualifications

• Bachelor's degree in Engineering; graduate degree or ASQ certification preferred.
• 8+ years product development/design assurance, incl. 5+ years with Class III devices.
• Deep knowledge of U.S. & international medical device regs (FDA, EU MDR, MDSAP).

Responsibilities

• Lead design assurance across multiple projects to meet schedule, budget and quality.
• Direct testing strategy including DV/V and human factors exploration.
• Ensure compliance with IEC 60601-1 and ISO 14971, 13485.
• Prepare regulatory submissions and CAPA investigations as needed.
• Mentor team members and train on standards and best practices.

Skills

Analytical skills

Problem solving

Communication

Cross-functional collaboration

English proficiency

Education

Bachelor's degree in Engineering

Graduate degree or ASQ certification preferred

Tools

SolidWorks CAD

Minitab

Agile PLM

Job description

Who we are

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.

Valencia (CA), United States

Valencia, CA - Hybrid (3 days/week on site, 2 days remote)

Senior Engineer, Design Assurance

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 TUV 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

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/add insurance
  • Additional supplemental life/add 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
• Tuition reimbursement
• Hearing aid discount for employees and family
• Internal social recognition platform

*Plan rules/offerings dependent upon group Company/location

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.