Job Description

Software Architects - REMOTE-YOU CAN BE LOCATED ANYWHERE IN THE UNITED STATES-highly prefer candidates to be in Central and Eastern time zones.

WE NEED Senior level Application Architect that has experience owning overall architecture for a cloud-based or Bluetooth connected medical device.  This includes product connectivity architecture (mobile app, tablets, web apps).  They are going to be responsible for writing all design and development specifications, be client facing and work directly with system architects, drive developers (code reviews, hitting timelines, etc.).  This is an Agile development environment where they are following all regulations and policies associated with IEC 62304. This person should have experience meeting pharmaceutical clients face-to-face to explain and describe the benefits of their products, architecture strategy, etc.  This is not a “hands-on” architect position in terms of coding.  

POSITION SUMMARY 

The Software Architect position will be working with the product and software engineering team to ensure different customer solutions are designed, architected, documented and implemented according to medical device design and development requirements from regulatory bodies.  These solutions include mobile, web, and web services that leverage the capabilities of the COMPANY platform. The platform is a medical IoT, cloud-based platform for the life science industry, and is used to manage, process, and store patient health and medical device data to be used for patient diagnosis and treatment.

We are looking for someone who thrives in a start-up environment and demonstrates:

• Intensely collaborative
• Passionately focused on the customer
• Detail oriented
• Disciplined executor of responsibilities
• Tenacious commitment to continuous improvement
• Relentless drive to win
• Intense curiosity on technology
• Flexibility and willingness to learn

Here is a glimpse of what you’ll do…

• Lead design, architecture, and development of software-based medical devices. Activities will encompass all facets and phases of software design and development, test and life cycle management, meeting all regulatory, quality, data privacy, and cybersecurity standards to realize complex, high-performing, and reliable software solutions.
• Collaborate with the systems engineering and product teams to understand and define customer products use cases and convert these use cases into software requirements and architecture and design implementations.
• Own and lead the software engineering team throughout the software development life-cycle, including sub-system architecture and design specifications, code review, unit and integration testing, software FMEA, performance analysis, reliability analysis, and root cause analysis.
• Ensure traceability of software requirements into software architecture and design specifications all the way down to base software units.
• Provide support for accurate and complete software verification and validation at the system and unit levels

Here is some of what you’ll need (required)…

• 7+ years of hands-on software development experience
• 7+ years of experience in software medical device development classified as Class 2 and/or Class 3 medical device
• DEMONSTRATED APPLIED EXPERTISE IN FDA DESIGN CONTROL REQUIREMENTS (21 CFR 820.30) AS APPLIED TO MEDICAL DEVICE SOFTWARE AND MEDICAL DEVICE REGULATIONS INCLUDING ISO 13485, ISO 14971, CYBERSECURITY, IEC 62366, AND IEC 62304
• DEMONSTRATED APPLIED EXPERTISE IN WRITING ARCHITECTURE AND DESIGN SPECIFICATIONS FOR CLASS 2 AND/OR CLASS 3 SOFTWARE-BASED MEDICAL DEVICE SOFTWARE WITH COMPLIANCE TO IEC 62304
• Experience in working in an environment following Agile methodology
• Demonstrated applied expertise with Software FMEA process
• Familiarity with SaMD development
• Experience leading nearshore and/or offshore development partners
• Familiarity with health and data privacy regulations

Here are a few examples of what you’ll get for the great work you provide:

• Full range of medical benefits, dental, vision, etc
• Life Insurance
• Matching 401K
• Paid Time Off

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