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Design and Development Documentation Specialist

Medical Informatics Corp

Medical Informatics Corp

Posted on Saturday, June 3, 2023

We Are

Medical Informatics Corp. (MIC) a medical software company that aims to save lives by improving how patients are monitored. Our solution, Sickbay, collects patient data, stores it, transforms it and delivers results to doctors and nurses in real-time. We continue to build on Sickbay to identify early warning signs of patient deterioration in data which was previously lost within hospitals. This allows us to provide predictive alerts to care providers who can remotely or locally diagnose the problem and intervene before symptoms become life-threatening.

You are

Are you a technology enthusiast who would like to work with a group of diverse, smart, innovative problem solvers in a rewarding, fast paced growth environment?

Are you an active learner interested in challenging the status quo to disrupt the current model of remote patient monitoring and predictive analytics in healthcare?

Would you like to work with a unique, state of the art FDA cleared platform that improves patient outcomes and ultimately saves patient lives?

Are you looking for a new opportunity with a clear path for advancement based on your success?

At Medical Informatics Corp, we are committed to:

  • Curiosity and the freedom to explore
  • A spirit of collaboration and understanding
  • Making sure the work you do is meaningful, fun and well balanced with the rest of life’s priorities

Duties and Responsibilities

  • Create and maintain software product development life cycle documentation, including software product descriptions, product user manuals, product labeling/indications for use, bill of materials, software requirements specifications, and implementation documentation in partnership with Engineering & Tech software development engineers.
  • Track quality system documentation through the software product development life cycle, including preparing meeting minutes for design reviews, document change orders and updates, and revising product documentation and forms as needed.
  • Maintain responsibility for Device Master Records (“DMR”) and Design History Files (“DHF”) at the close of each product project and audit project folders to ensure all the required documentation has been completed and is readily available.
  • Create training materials, such as slide decks and quizzes, for MIC employee training.
  • Assist the Engineering & Tech Dept. to create and maintain internal standard operating procedures, work instructions, and corresponding quality system documentation. All documents must align with company document control procedures to maintain consistency by utilizing authorized templates and controlled documents.
  • Act as a Subject Matter Expert (“SME”) for implementation of the electronic Quality Management System (“eQMS”) and serve as the main point of contact when it relates to training and roll-out to the Engineering & Tech teams.
  • Assist in documenting non-conformances and complaints in the eQMS.
  • Assists in product validation and verification testing for new version release sprint testing.
  • Assist in internal and external audits by maintaining files and retrieving requested documents during audits.
  • Follow regulatory, industry standards, and cGDP guidelines at all times.
  • Function as an information source to Engineering and Tech software engineers and various company departments when quality issues arise.
  • Work in conjunction with the Director of Compliance to assist in the development of special department projects.
  • Perform other Legal & Compliance or Engineering & Tech duties as assigned.
  • 5% travel required.

Required Qualifications

  • Bachelor of Computer Science or Engineering or Technology, Technical Writing related field or equivalent
  • 2 years of work experience in medical device industry
  • 2 years experience with ISO 13485: 2016, ISO 14971: 2019, 21 CFR 820 regulations.
  • 2 years of work experience with Software Product Development Technical Writing.
  • Experience participating in internal and external audits
  • Excellent writing and verbal communication skills
  • Excellent organizational skills with a high level of attention to detail
  • Excellent time and project management skills
  • Comfortable learning and using new technologies - GitHub, Confluence, Greenlight Guru (eQMS), Smartsheets, and G-suite.
  • Ability to multitask during design reviews, adequately taking notes as needed and making document edits as necessary

    • Ability to self-initiate and work independently on projects

    • Ability to manage multiple concurrent projects from initiation to completion

    • Ability to edit and proofread colleagues' work

    • Ability to generate content on technical topics

    • Ability to actively and effectively collaborate with team members and across departments

Preferred Qualifications

  • Professional certification in Quality, Compliance, or Regulatory Affairs is a plus
  • Experience in preparing FDA 510(k) applications for software as a medical device.
  • Experience with Greenlight Guru (eQMS platform), Github and /Smartsheet.
  • Demonstrate a basic understanding of computer software product development.

Your mission

The Design and Development Documentation Specialist is responsible for authoring, formatting, tracking, storing, reviewing, updating, and maintaining control over documentation for Legal & Compliance and Engineering & Tech departments. These documents include policies, procedures, work instructions, forms, records, training slides, etc. The individual is responsible for maintaining Engineering & Tech’s design and product development documentation, including documentation for MIC’s products, ensuring compliance with internal policies, procedures, industry standards, and regulations. This position acts as an information source for quality and compliance-related issues or the Engineering and Tech. Dept. They will lead with an attitude that promotes a culture of quality and compliance, supportive of collaboration, accountability, and innovation.

Your reward

  • Competitive market value-based salary for a Design and Development Documentation Specialist
  • Health Benefits (med/den/vis/company paid STD/LTD & Life Ins./HSA's/FSA’s)
  • Paid Time Off (PTO)
  • 14 Paid Holidays
  • 401k Investment Opportunity
  • Flexible work schedule
  • Knowing that the work you do makes a difference in the lives of patients and the clinicians that take care of them
  • Working with a great team with different backgrounds
  • Increase personal knowledge base

"This position requires in-person meetings at the Houston office or at client sites. COVID-19 vaccination is mandatory, unless otherwise accommodated, in accordance with company policy."

Required submissions

Please submit all of the following. Incomplete applications will not be considered!

  • Resume
  • Cover letter (Why do you want to work for MIC? What makes you a great candidate?)

Kindly provide us with:

  • Three references with contact information (We will not contact them until later in the hiring process)
  • A joke (Something that makes you laugh!)
  • Create a new portmanteau, define that portmanteau, and use it in a sentence. (Tell us the two words you used to create one!)