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 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: $