Senior Engineer, Design Assurance

Sonova Group; Santa Clarita (CA); Hybrid; USD 100,320 - 150,480; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k plan with company match

TeleHealth options

Tuition reimbursement

Job summary

Sonova Group is seeking a Senior Engineer, Design Assurance, based in Valencia, CA. This hybrid role focuses on ensuring compliance with procedures and regulations in the development of Cochlear Implant Technology. The ideal candidate will oversee design assurance for multiple projects while working closely with a multidisciplinary team.

The candidate should have a Bachelor's degree in Engineering and at least 8 years of relevant experience, particularly in Class III medical devices. Extensive knowledge of regulatory standards and strong analytical skills are required.

Qualifications

• Minimum 8 years of product development or design assurance experience with Class III medical devices.
• Strong knowledge of U.S. and international medical device regulations.
• Excellent communication and technical skills.

Responsibilities

• Manage Design Assurance aspects of projects to align with objectives.
• Communicate project progress, risks, and issues.
• Prepare documentation for regulatory submissions.

Skills

Regulatory compliance expertise

Analytical skills

Problem-solving skills

Cross-functional collaboration

Technical skills

Education

Bachelor’s degree in Engineering or related field

Graduate degree or ASQ certification preferred

Tools

Microsoft Office

Minitab

SolidWorks CAD

Job description

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 21CFR820, ISO13485, ISO 14971, IEC 60601, MDSAP and MDR.

Responsibilities

• 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.

Qualifications

• 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, SolidWorks CAD or equivalent; second‑language proficiency and Agile PLM experience considered a plus.

Connectivity Requirement

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

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/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/ID theft 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.