Senior Engineer, Design Assurance

Valencia CA Hybrid (3 days/week on site 2 days remote)

Senior Engineer Design Assurance

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.

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 CAPAs.
• 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

More about you:

• Bachelors degree in Engineering or a related technical discipline required with training in Design for Manufacturability Design for Six Sigma and Lean principles; graduate degree in Engineering ASQ certification or related advanced technical education preferred.
• 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 CFRand 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.
• 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.
• Proficiency in English Microsoft Office Minitab (or equivalent statistical software) and SolidWorks CAD (or equivalent) with second-language proficiency Agile PLM experience and other product lifecycle management systems considered a plus.

A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova

Dont meet all the criteria If youre willing to go allin and learn wed love to hear from you!

We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app telegram carrier pigeon or any other format that does not include speaking with an actual human. If you are offered a job without speaking with someone please contact Sonova Human Resources

What we offer:

• 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

*Plan rules/offerings dependent upon group Company/location.

This roles pay range is between: $100320/yr -$150480/yr. This role is also bonus eligible.

How we work:

At Sonova we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team-customized hybrid work model empowers teams to balance individual needs with business goals offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.