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

As a software engineer, you will work with a small and agile team of experienced hardware and software engineers to develop new product applications and support existing products. In doing so, you’ll work closely with customers and clinical trial partners, as well as the Accure commercial team, to better understand clinical applications, resolve issues, and provide support.

Description

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

Salary

$110,000 - $160,000 per year