Axonicsposted 19 days ago
$100,000 - $150,000/Yr
Full-time • Mid Level
Irvine, CA
Miscellaneous Manufacturing

About the position

This position is responsible for the design, development and manufacturability of software applications related to product(s)/system(s) in accordance with the company's Quality System, regulatory standards and requirements, and customer/user needs. This position complies with Quality System by engaging in appropriate levels of GMP/ISO test methodologies, adherence to Quality System Design Controls, and applies proper documentation skills.

Responsibilities

  • Designs and develops software applications that meet customer needs.
  • Writes high-quality, clean, and flawless code to complete functional applications on schedule.
  • Implements, tests, troubleshoots, and debugs source code for software applications.
  • Understands customer requirements and how they translate to application features.
  • Collaborates with engineering and marketing teams.
  • Evaluates existing applications to update and add new features.
  • Ensures mobile application compliance to appropriate regulations.
  • Assists in design and development of cloud backend as necessary.
  • Performs other duties as assigned by supervisor.

Requirements

  • Excellent analytical and problem-solving skills.
  • Able to think creatively to find solutions.
  • Experience in developing mobile applications in an FDA regulated environment or other regulated industry.
  • Experience working with domestic and international regulatory agencies.
  • Knowledge of ISO 13485 and FDA QSR is desired.
  • Sound knowledge of software engineering principles and practices.
  • Knowledge of programming languages such as Swift, Java, Dart, or Objective-C and mobile operating systems and platforms such as iOS and Android.
  • Knowledge of API design.
  • Excellent written, verbal, and visual communicator.
  • Detail oriented and excellent time-management skills.
  • Knowledge and use of OOP design principles.
  • Successfully demonstrated collaboration with cross-functional teams.

Nice-to-haves

  • Knowledge of UI/UX design principles.
  • Experience in interfacing BLE enabled medical devices to mobile applications.
  • Detailed knowledge of BLE stacks and BLE API on mobile platforms.
  • Knowledge of cybersecurity considerations in an FDA regulated framework.

Benefits

  • Competitive salaries
  • Performance-based incentives
  • Employer paid benefits programs
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