Job Description

About KNOW Bio

KNOW Bio, LLC is a life science company redefining the standards of care in a number of diseases and medical conditions. Utilizing our extensive catalog of intellectual property in the fields of Nitric Oxide and precision light therapy, we form subsidiaries that develop unique treatments to revolutionize the standard of care for many indications. KNOW Bio then supports each subsidiary by forming teams of experienced and talented personnel – at both the KNOW Bio and subsidiary levels – to accelerate the development and deployment of those treatments.

Opportunity

We are searching for a self-motivated Software Engineer to join our talented engineering team.The incumbent software engineer will play a pivotal role in the development, implementation, and maintenance of software and firmware for new and existing product lines.

Applicants must be authorized to work for any employer in the United States. We are unable to sponsor or assume responsibility for on-going sponsorship of an employment Visa at this time.

Job Title: Software Engineer

Reports To: Director of Engineering

Key Responsibilities:

• Complete software development deliverables (including plans, requirements, and design documents) in compliance with IEC 62304 and quality procedures
• Provide hands on technical support on mobile application or embedded software across ongoing cross-functional projects
• Execute duties and leverage resources, including vendors and consultants, in the most efficient manner possible (balancing cost and effectiveness) to ensure the company will maintain developmental timelines without sacrificing quality standards
• Conduct, document, and report software verification activities
• Conduct periodic assessments in accordance with the Cybersecurity Management Plan
• Investigate anomalies and unexpected results to determine and understand the root cause
• Track and communicate progress, identify potential risks or barriers, and present solutions to keep projects on-track
• Perform duties and other analyses as requested by members of management
• Adhere to and ensure compliance with the quality system

Required Skills & Qualifications:

• BSc or MSc in Computer Science, Software Engineering, or related field
• 5+ years of experience in software development, with at least 3 years in medical device medical device industry and within a Quality System compliant with 21 CFR 820 or ISO 13485
• Demonstrated experience with C++ programming and embedded systems development
• Ability to prioritize and manage multiple projects in a fast-paced environment with minimal supervision while maintaining strong attention to detail
• Self-motivated team player with a proactive approach to problem-solving and decision-making
• Flexibility to quickly adapt to changing priorities and manage multiple tasks, including performing tasks outside normal job hours, duties, and education
• Exceptional interpersonal skills, effective written and verbal communication, problem solving, and decision-making skills

Desired Skills and Qualifications:

• Proficiency in mobile application development using Flutter framework
• Experience with Amazon Web Services (AWS) and cloud infrastructure
• Proficiency in Bluetooth Low Energy (BLE) protocol and wireless communication systems
• Knowledge of additional programming languages such as Python, Java, or C#
• Hands-on experience with version control systems (e.g. Git)
• Knowledge of project management tools such as Microsoft Project, Smartsheet, or other project management software
• Familiarity with Medical Device Cybersecurity Standards such as AAMI TIR 57 and IEC 81001-5-1

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

In the typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, use hands and fingers (i.e. typing) and occasional lifting up to 20 pounds. There will be an occasional requirement to work outside of normal business hours, consistent with other Manager-level positions. Some travel may be required (5-10%).

KNOW Bio maintains a drug-free workplace and performs pre-employment and employment substance abuse testing and background verification checks.

KNOW Bio is an equal opportunity employer and does not discriminate against any employee or applicant for employment. We encourage and foster diversity in the workplace.

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