Senior Engineer, Design Assurance

Sonova USA Inc.
paid holidays, 401(k)
United States, California, Valencia
Jan 08, 2025
Who we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life's unforgettable moments. We offer exceptional career opportunities through market-leading brands from consumer to medical, products and services that keep pushing hearing care forward, and a culture where you can quickly belong and perform at your best. If you want the freedom to explore, opportunities to grow, and make positive change on people lives through your work, this is the place for you. Join Sonova. Create sense. Valencia (CA), United States Senior Engineer, Design Assurance Overview The Senior Professional System Engineering and Architecture designs and develops the architecture of systems, platforms, services and applications for Sonova. What you'll do: Requirements discovery as solicited from Engineering, Marketing, Clinical, and Regulatory stakeholders Tracing requirements throughout their lifecycle using commercial RM software Simulation of design concepts under expected use conditions using electrical, mechanical, or multiphysics analysis software Identification and interpretation of recognized standards for medical device performance (e.g. EN 45502, IEC 60601, etc.) Ensure design meets and exceeds product specifications, regulatory requirements, and international safety standards such as IEC 60601-1 Feasibility testing of early prototype components or systems Develop test protocols and reports, and execute testing to support regulatory submissions Prepare documentation for and support regulatory submissions (USA, EU, International) Support human factors and usability engineering by developing plans and tests to comply with IEC 62366 Educate different departments on compliance of medical devices per international standards Design verification and validation according to a precise quality system Experienced in hands-on engineering testing Independent research and literature review experience Broad technical skills; conversant in Systems, Mechanical, Electrical, and Biomedical Engineering, Materials Science, Biology or Neurophysiology, and Statistics Design and execution of experiments; generation of peer reviewed data is ideal Strong analytical skills, attention to detail and logic Strong technical writing and communication skills Ability to work productively and proactively with technical, multi-disciplinary product teams Strong organizational and work planning skills, detail oriented Ability to manage multiple tasks in a time sensitive environment Self-motivated with a strong work ethic Familiar with FTA, FMEA, HALT, etc. Experience with risk management methodology. Other duties as assigned. Travelling Requirement:up to 20% What you bring to the team: Education B.S. in Engineering, Physics, or related applied or physical sciences is required; graduate degree with research is preferred Nice to Have Master's degree in computer science engineering Work Experience 5 years experience in product development is required; time in academia or any highly regulated industry may apply to experience Nice to Have Previous Class 3 Medical device experience Personal Competencies Must be able to work with all levels of management and ability to manage a team of engineers. Social Competencies Ability to work under pressure and meet project timelines across departments Professional Competencies Must be able to work with all levels of management and peers. Ability to maintain professionalism among peers and communicate effectively will all levels of the organization Language(s)/ Level English/ Fluent IT Skills Knowledge of OWASP-10 and SANS CWE-25 Nice to Have Salesforce IT Skills Familiarity with Microsoft Office Our offer: Exciting and challenging work environment Comprehensive benefits package Training and development opportunities - we believe every employee deserves a development plan. Come, learn, and grow with us! Don't meet all the criteria? If you're willing to go allin and learn we'd love to hear from you! We love to work with great people and strongly believe that a diverse team makes us better. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of race, color, creed/religion, sex, sexual orientation, marital status, age, mental or physical disability. We thank all applicants in advance; however only individuals selected for an interview will be contacted. All applications will be kept confidential. Sonova is an equal opportunity employer. Applicants who require reasonable accommodation to complete the application and/or interview process should notify the Senior Manager, Human Resources. Pay Ranges:$ 93,600/yr - $140,400/yr Based on location Health Benefits & Perks: 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 Short/Long-Term Disability coverage (STD/LTD) STD LTD Buy-ups available Accident/Hospital Indemnity coverage Legal/ID Theft Assistance PTO & paid holidays* Employee Assistance Program *Plan rules/offerings dependent upon group Company/location. Sonova is an equal opportunity employer We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate's ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.