Senior Engineer, Systems Design Assurance

Sonova•Valencia, CA

47d•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

Graduate degree in Research
Project Management/ leadership training and/or experience preferred.

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.

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.