What are the responsibilities and job description for the Senior Engineer, Design Assurance (Valencia (CA), United States) position at Sonova AG?
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
Nice to Have
Work Experience
Nice to Have
Personal Competencies
Social Competencies
Professional Competencies
Language(s) / Level
IT Skills
Nice to Have
IT Skills
Our offer :
Don't meet all the criteria? If you're willing to go all in 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 :
Additional supplemental life / ad&d coverage available
STD LTD Buy-ups available
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.
Salary : $93,600 - $140,400
