Apply on Employer Site

Sonova Group · 9 hours ago

Senior Engineer, Systems Design Assurance

Santa Clarita, CA

Full-time

Hybrid

Mid, Senior Level

$94K/yr - $142K/yr

5+ years exp

Sonova Group is a growing company within the cochlear implant industry, seeking a Senior Engineer in Systems Design Assurance. The role involves collaborating with multidisciplinary teams to ensure product design intent is effectively realized, emphasizing regulatory compliance and innovative product development.

Medical Device

H1B Sponsor Likely

Responsibilities

Collaborate with cross-functional teams (Engineering, Marketing, Clinical, Regulatory) to gather and define product requirements

Interpret and apply international medical device standards (e.g., EN 45502, IEC 60601, IEC 62366) to ensure regulatory and safety compliance

Conduct feasibility testing and hands-on evaluation of early prototypes and components

Develop and execute test protocols, generate reports, and support global regulatory submissions

Lead design verification and validation activities in accordance with a rigorous quality system

Support usability engineering and cross-departmental education on compliance with medical device standards

Perform additional engineering duties as assigned to support product development and compliance efforts

Qualification

Design verificationRegulatory complianceProduct developmentMedical device standardsProject managementUsability engineeringEnglish fluencyCross-functional collaboration

Required

B.S in Electrical or Computer Science Engineering

Minimum 5 years' experience in product development is required (time in academia or any highly regulated industry may apply to experience)

Familiarity with CFR Medical Devices, ISO 13485, ISO 14971, IEC 62366, IEC 62304

English/ Business fluent

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

Preferred

Graduate degree in Research

Project Management/ leadership training and/or experience preferred

Benefits

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

Tuition reimbursement

Hearing aid discount for employees and family

Internal social recognition platform

Plan rules/offerings dependent upon group Company/location.

Company

Sonova Group

Glassdoor3.7

Around 25% of the world’s population is living with hearing loss.

Founded in 1947

Stäfa, CH

10001+ employees

http://www.sonova.com

H1B Sponsorship

Sonova Group has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2024 (3)

2023 (1)

2022 (3)

2020 (1)