Sonova Valencia , CA 91385
Posted 1 week ago
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:
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 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:
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 guaranteeevery 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.
Sonova