Avation Medical

General Description:

Apply your creativity and passion to develop innovative medical devices that can greatly improve patients’ lives. We take pride in a truly entrepreneurial environment, unique technical challenges and a collaborative culture. We welcome you to explore Avation and be part of a talented team and an exciting company.

Key Responsibilities:

• Lead hardware and software validation strategy for medical device systems
• Plan, conduct and document tests per standards such as IEC60601 and IEC62304
• Coordinate Verification and Validation tests, author protocols and execute tests
• Create trace matrix correlating system requirements and validation plans
• Plan and build necessary setups, equipment, analysis tools and fixtures for testing
• Develop and validate automated manufacturing tests for systems and sub-systems
• Create reports, interpret results and provide statistical summaries
• Analyze system architecture and integration of hardware and software designs
• Provide timely feedback on issues, risks and system improvements
• Ensure adherence to design controls and risk management per ISO 14971
• Work in a cross-functional team and actively contribute to all aspects of the project

 

Qualifications:

• Bachelor’s degree in Electrical, Computer Science or Systems Engineering
• 5-8 years of experience in medical device product lifecycle development
• Experience with test planning, execution and protocols in a regulatory environment
• Knowledge of standards including IEC 60601, IEC 62304, 62366, ISO 14971
• Hands-on experience with testing/analysis tools such as Matlab, Labview or Python
• Experience with system integration, architecture, and software-driven medical devices
• Independent, creative, collaborative with strong positive can-do attitude

  

Avation Culture

We are seeking candidates who are:

• Driven by the desire to bring innovative medical technologies to market
• Passionate about applying themselves to improve the lives of patients
• Intellectually curious, motivated by innovation and open to new ideas
• Leaders who take individual ownership while placing high value on teams
• Energetic and enjoy working in a fast-paced creative environment

 

Location:  Valencia, CA

 

Search Firm Representatives Please Read Carefully

Avation Medical does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.