Senior Engineer, Design Assurance

Sonova AG • Santa Clarita, CA

1d • $100,320 - $150,480 • Hybrid

About The Position

The Senior Design Assurance Engineer is responsible for compliance to procedures and regulations for Design Control of Software, Firmware and Hardware associated with Cochlear Implant Technology. Works collaboratively as the DA representative within a multidisciplinary product development team to ensure the design intent of products is realized effectively and efficiently, including compliance with 21CFR820, ISO13485, ISO 14971, IEC 60601, MDSAP and MDR.

Requirements

• Bachelor’s degree in Engineering or a related technical discipline required, with training in Design for Manufacturability, Design for Six Sigma, and Lean principles
• Minimum 8 years of product development and/or design assurance experience, including at least 5 years supporting Class III medical devices, with demonstrated success applying Quality Management principles throughout the product lifecycle and hands-on engineering testing experience.
• Strong knowledge and application of U.S. and international medical device regulations and quality systems, including 21 CFR 807, 803, 806, and 820, EU MDR, MDSAP, and experience working directly with regulatory agencies such as FDA, PMDA, MHLW, and TÜV during and outside of audits.
• Proven ability to work effectively in cross-functional matrix organizations, collaborate with diverse stakeholders, multitask in fast-paced environments, adapt to changing priorities, and lead through sound judgment and quality-focused decision-making.
• Excellent analytical, problem-solving, communication, and technical skills, with the ability to drive results, maintain accountability, apply attention to detail, and communicate effectively both verbally and in writing.
• Proficiency in English, Microsoft Office, Minitab (or equivalent statistical software), and SolidWorks CAD (or equivalent)

Nice To Haves

• graduate degree in Engineering, ASQ certification, or related advanced technical education preferred.
• Broad technical expertise across disciplines such as Mechanical, Electrical, Biomedical and Systems Engineering, Materials Science, Biology, Neurophysiology, and Statistics, with experience in cochlear implants, medical device electromechanical systems, consumer electronics, biomedical restoration technologies, and AI tools such as ChatGPT, Gemini, and Claude considered advantageous.
• second-language proficiency, Agile PLM experience, and other product lifecycle management systems considered a plus.

Responsibilities

• Manages all Design Assurance aspects of multiple related projects to ensure the overall program is aligned to and directly supports the achievement of 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
• Identifies, interprets and provides expertise to the organization on the implementation of international standards (ISO 14971, IEC 60601-1, ISO 13485, particular standards, etc.)
• Ensures designs can 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, usability engineering etc.
• Identifies and leads process improvements to ensure consistent implementation of internal requirements and external regulations and standards.
• As needed, participates in or leads the investigations and analysis of product changes and CAPA’s.
• Prepares documentation for and support regulatory submissions (USA, EU, International)
• Creates and delivers training to ensure compliance of medical devices per international standards
• Mentors, trains and otherwise provides guidance to newer or less experienced team members, leveraging product skills and experience

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior