Senior Engineer, Design Assurance

Senior Engineer, Design AssuranceValencia, 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 21CFR820, ISO13485, ISO 14971, IEC 60601, MDSAP and MDR.ResponsibilitiesManages 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.QualificationsBachelor'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, SolidWorks CAD or equivalent; second‑language proficiency and Agile PLM experience considered a plus.Connectivity RequirementMinimum 200 Mb/s download and 10 Mb/s upload internet speed required for remote/hybrid functionality.BenefitsMedical, dental and vision coverage*Health Savings, Health Reimbursement, Flexible Spending/Dependent Care AccountsTeleHealth options401k plan with company match*Company‑paid life/additional disability insuranceAdditional supplemental life/disability coverage availableCompany‑paid short/long‑term disability coverage (STD/LTD); STD/LTD buy‑ups availableAccident/Hospital indemnity coverageLegal/ID theft assistancePTO, floating Diversity Day and paid holidays*Paid parental bonding leaveEmployee Assistance Program with 24/7 mental health support hotline and company‑paid counseling sessionsRobust internal career growth opportunitiesTuition reimbursementHearing aid discount for employees and familyInternal social recognition platformPlan 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.#J-18808-Ljbffr