Senior Engineer, Design Assurance

Senior Engineer, Design Assurance

Valencia, CA – Hybrid (3 days on site, 2 days remote).

Responsible for compliance to procedures and regulations for Design Control of Software, Firmware and Hardware associated with Cochlear Implant Technology, working collaboratively as the DA representative within a multidisciplinary product development team to ensure design intent is realized effectively and efficiently, including compliance with 21

CFR
820, ISO
13485, ISO 14971, IEC 60601, MDSAP and MDR.

• Manages all Design Assurance aspects of multiple related projects to align the program with strategic objectives (schedule, budget, quality, resources).
• Leads simulation of design concepts under expected and worst‑case use conditions.
• Communicates project progress, risks, issues and mitigations across and up the organization.
• Provides expertise on implementation of international standards (ISO 14971, IEC 60601‑1, ISO 13485, etc.).
• Ensures designs meet product specifications, regulatory requirements, and international safety standards such as IEC 60601‑1.
• Responsible for testing strategy and execution, including feasibility, DV&V, human factors and usability engineering.
• Identifies and leads process improvements to ensure consistent implementation of internal requirements and external regulations and standards.
• Participates in or leads investigations and analysis of product changes and CAPAs.
• Prepares documentation for and supports regulatory submissions (USA, EU, International).
• Creates and delivers training to ensure compliance of medical devices per international standards.
• Mentors, trains and provides guidance to newer or less experienced team members.

• Bachelor’s degree in Engineering or a related technical discipline; graduate degree or ASQ certification preferred.
• Minimum 8 years of product development and/or design assurance experience, including at least 5 years supporting Class III medical devices.
• Strong knowledge and application of U.S. and international medical device regulations and quality systems, including 21 CFR 807, 803, 806, 820; EU MDR and MDSAP; experience working directly with regulatory agencies such as FDA, PMDA, MHLW, and TÜV during audits.
• Proven ability to work effectively in cross‑functional matrix organizations, collaborate with diverse stakeholders, multitask in fast‑paced environments, and lead through sound judgment.
• Excellent analytical, problem‑solving, communication, and technical skills; able to drive results and maintain accountability.
• Broad technical expertise across Mechanical, Electrical, Biomedical, Systems Engineering, Materials Science, Biology, Neurophysiology, and Statistics; experience in cochlear implants and related technologies is advantageous.
• Proficiency in English, Microsoft Office, Minitab or equivalent, Solid Works CAD or equivalent; second‑language proficiency and Agile PLM experience considered a plus.

• Minimum 200 Mb/s download and 10 Mb/s upload internet speed required for remote/hybrid functionality.

• Medical, dental and vision coverage*
• Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
• Tele Health options
• 401k plan with company match*
• Company‑paid life/additional disability insurance
• Additional supplemental life/disability coverage available
• Company‑paid short/long‑term disability coverage (STD/LTD); STD/LTD buy‑ups available
• Accident/Hospital indemnity coverage
• Legal/ assistance
• PTO, floating Diversity Day and paid holidays*
• Paid parental bonding leave
• Employee Assistance Program with 24/7 mental health support hotline and company‑paid counseling sessions
• Robust internal career growth opportunities
• Tuition reimbursement
• Hearing aid discount for employees and family
• Internal social recognition platform
• Plan rules and offerings depend on group, company, and location.

This role's pay range is $100,320/yr – $150,480/yr. This role is also bonus eligible.

Sonova is an equal opportunity employer and guarantees equal treatment in employment regardless of protected status.