Senior Engineer, Design Assurance

$140,400 - $140,400/Yr

Sonova USA - Santa Clarita, CA

Full-time - Mid Level

Santa Clarita, CA

Merchant Wholesalers, Nondurable Goods

About the position

The Senior Engineer, Design Assurance at Sonova USA Inc. is responsible for designing and developing the architecture of systems, platforms, services, and applications. This role involves collaborating with various stakeholders to ensure that medical devices meet regulatory requirements and international safety standards. The engineer will conduct feasibility testing, develop test protocols, and support regulatory submissions while educating teams on compliance standards.

Responsibilities

• Requirements discovery from Engineering, Marketing, Clinical, and Regulatory stakeholders
• Tracing requirements throughout their lifecycle using commercial RM software
• Simulation of design concepts under expected use conditions using analysis software
• Identification and interpretation of recognized standards for medical device performance
• Ensure design meets and exceeds product specifications and regulatory requirements
• Feasibility testing of early prototype components or systems
• Develop test protocols and reports, and execute testing for regulatory submissions
• Prepare documentation for and support regulatory submissions
• Support human factors and usability engineering
• Educate departments on compliance of medical devices
• Design verification and validation according to a quality system
• Conduct hands-on engineering testing
• Perform independent research and literature review
• Utilize broad technical skills in various engineering fields
• Design and execute experiments; generate peer-reviewed data
• Demonstrate strong analytical skills and attention to detail
• Communicate effectively with technical, multi-disciplinary product teams
• Manage multiple tasks in a time-sensitive environment
• Demonstrate self-motivation and a strong work ethic
• Familiarity with risk management methodologies

Requirements

• B.S. in Engineering, Physics, or related applied or physical sciences
• 5 years experience in product development
• Strong analytical skills and attention to detail
• Strong technical writing and communication skills
• Ability to work productively with multi-disciplinary teams
• Familiarity with FTA, FMEA, HALT, etc.

Nice-to-haves

• Graduate degree with research
• Master's degree in computer science engineering
• Previous Class 3 Medical device experience
• Knowledge of OWASP-10 and SANS CWE-25
• Familiarity with Microsoft Office
• Experience with Salesforce

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
• Short/Long-Term Disability coverage
• Accident/Hospital Indemnity coverage
• Legal/ID Theft Assistance
• PTO & paid holidays
• Employee Assistance Program