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Principal System Engineer

Engineering | Agoura Hills, CA | Full Time

Job Description

Principal System Engineer

Caldera Medical’s Mission - To Improve the Quality of Life for Women!

Position Summary: The Principal System Engineer will lead development of innovative medical devices, including design, system integration, product requirements and documentation. 

 

Responsibilities: 

  • Conceptualize, design and develop complex medical devices and instruments
  • Be the technical lead for hardware and software development
  • Develop innovative products from early concepts to market introduction
  • Understand clinical and user needs, and translate into practical system configuration
  • Perform circuit board design and schematic for RF systems
  • Conduct design review, risk assessment and project documentation
  • Plan, document and execute testing for R&D, validation and Manufacturing needs
  • Write and manage basic firmware and software validation protocols
  • Review and support compliance to regulatory requirements per IEC, FDA and FCC
  • Support engineering tests using Labview, test scripts and data acquisition systems

 

Minimum Qualifications:

  • Bachelor of Science in Electrical Engineering or equivalent
  • Minimum 8 years of work experience in electrical, systems or software functions
  • At least 5 years of experience in development of medical devices
  • Expert in modeling, analysis, simulation, and prototyping tools

Preferred qualification:

  • MS in Electrical or Software Engineering
  • Familiarity with technologies such as RF, microwave, medical imaging and sensors
  • Knowledge of regulatory standards such as IEC 60601, IEC 62304 and Usability
  • Deep understanding of FMEA, risk analysis, quality systems and design controls
  • Ability to plan, set up and run tests for research and product verification
  • Positive thinking, energetic with team-building and leadership skills

 

About Caldera Medical:

Caldera Medical is a growth stage medical device company focused on designing, manufacturing, and marketing products into the Gynecology, Urology and Urogynecology surgical markets.  We are searching for highly motivated, dynamic and results oriented individuals to join us in improving the quality of the patients we serve.

The Culture:

  • A Culture of family and team…not a corporate goliath where you’re just another number
  • All employees get a seat at the table and have influence with management
  • Women’s Health Initiative - Giving back to those who can’t afford treatment 
    • Goal to treat 1 million women suffering from incontinence by 2025!

The Benefits:

  • Competitive Compensation
  • Basic Life and AD&D
  • Unlimited Vacation
  • 6 Weeks Paid Maternity Leave Supplement
  • Being surrounded by talented and engaged employees
  • Medical / Dental Benefits – 75% paid for employee and family members
  • 401(k) with 4% matching contributions

Learn more about us on Glassdoor - https://www.glassdoor.com/Reviews/Caldera-Medical-Reviews-E356568.htm

Caldera Medical is an equal opportunity employer and considers all candidates for employment regardless of race, color, religion, sex, national origin, citizenship, age, disability, marital status, military or veteran's status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law.