Senior Engineer, Systems Design Assurance

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:

• Requirements discovery as solicited from Engineering, Marketing, Clinical, and Regulatory stakeholders
• Identification and interpretation of recognized standards for medical device performance (e.g. EN 45502, IEC 60601, etc.)
• Ensure design meets and exceeds product specifications, regulatory requirements, and international safety standards such as IEC 60601-1
• Feasibility testing of early prototype components or systems
• Develop test protocols and reports, and execute testing to support regulatory submissions
• Prepare documentation for and support regulatory submissions (USA, EU, International)
• Support human factors and usability engineering by developing plans and tests to comply with IEC 62366
• Educate different departments on compliance of medical devices per international standards
• Design verification and validation according to a precise quality system
• Experienced in hands-on engineering testing.
• Other duties as assigned.

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

Don't meet all the criteria? If you're willing to go allin and learn we'd 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 role's pay range is between $94,400/yr - $141,600/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.