Accure Acne, Inc. Senior Software Engineer – Medical Devices Boulder, CO · Full time

Apply for Senior Software Engineer – Medical Devices

This is a roll-up-your-sleeves, do-what-it-takes job.  It’s exciting and rewarding work, and a zest for developing cutting edge solutions that help people is a key to success.

Specific duties and responsibilities include, but are not limited to:

·      Participate in new product development projects through creation of software requirements specifications, full-stack programming, testing and validation. 

·      Participate in the support and sustaining development of existing software applications

·      Write software validation protocols and reports for new and revised software applications. 

·      Perform software validations

·      Create and maintain FDA compliant software Design History Files (DHF).

·      Support quality system compliance with FDA QSR and ISO 13485, and regulatory submissions

·      Analyze software issues to find root cause and develop solutions

·      Assist in the research & development of new device technologies and capabilities

·      Perform analysis and hands-on laboratory work

·      Work closely with principal investigators on clinical trials and application development

·      Travel to clinics, conferences, etc., as needed.

Qualifications

·      BS in software engineering or computer science or other engineering/science background with suitable technical experience

·      Experience with software management processes, such as agile development, version control, etc.

·      5 years of experience developing technical software

·      2 years of experience in the medical device industry

·      1 year of experience with C#

·      High degree of initiative and self-motivation with a strong sense of accountability 

·      Ability to work effectively in a team environment and build strong working relationships 

·      Ability to effectively problem-solve through critical thinking and root-cause analysis with minimal direction and make decisions with confidence 

·      Excellent organizational skills and attention to detail 

·      Strong communication skills, both oral and written 

·      Ability to prioritize, multi-task and adapt to change 

·       Ability to work in a fast-paced, start-up medical device company

·      Familiarity of quality systems regulations i.e., FDA QSR, ISO 13485

·      Ability to interact professionally and positively with external partners and customers

·      Comfortable working in clinical environments (physician offices, hospitals)

·      Willingness to work in the company office full time*

·      Willingness to travel up to 10% of the time annually

*Working remotely is allowed if approved by a manager and only as an exception

Specific Skills Required

·      C# development experience using Microsoft Visual Studio

·      Experience developing real-time, multithreaded, event-driven software

·      Experience developing safety-critical applications

·      Experience integrating firmware and hardware interfaces 

Desired Skills

·      Exposure to mathematical algorithms for signal or image processing

·      C/C++ for embedded microprocessors (Arduino, etc)

·      Implementation of remote connectivity and automated data reporting solutions

·      Development and support of medical devices