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Senior Engineer, Systems Design Assurance
Senior Engineer, Systems Design AssuranceSonova International • Valencia, California, USA
Senior Engineer, Systems Design Assurance

Senior Engineer, Systems Design Assurance

Sonova International • Valencia, California, USA
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  • [job_card.full_time]
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Valencia CA Hybrid

Senior Engineer Systems Design Assurance

To work as part of a multidisciplinary product development team in a growing company within the expanding cochlear implant industry to ensure the design intent of products is realized effectively and efficiently.

Design Assurance at Advanced Bionics emphasizes scientific and technical contribution to the requirement management and design verification processes. Through early and thorough analysis of targets and capabilities we ensure predictable development while continuing to innovate.

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

More about you :

  • B.S in Electrical or Computer Science Engineering

Nice to have : Graduate degree in Research

  • Minimum 5 years experience in product development is required (time in academia or any highly regulated industry may apply to experience).
  • Nice to have : Project Management / leadership training and / or experience preferred.

  • 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

    Dont meet all the criteria If youre willing to go allin and learn wed love to hear from you!

    We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app telegram carrier pigeon or any other format that does not include speaking with an actual human. If you are offered a job without speaking with someone please contact Sonova Human Resources

    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
  • Tuition reimbursement
  • Hearing aid discount for employees and family
  • Internal social recognition platform
  • Plan rules / offerings dependent upon group Company / location .
  • This roles pay range is between $94400 / yr - $141600 / 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.

    Required Experience :

    Senior IC

    Key Skills

    Electrical Engineering,SOC,PCB,Warehouse Management,Warehouse Experience,CAD,Creo,SolidWorks,Data Mining,Digital design,Mechanical Engineering,Autocad

    Employment Type : Full-Time

    Experience : years

    Vacancy : 1

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