Software Engineer

Actalent • Port Saint Lucie, FL • 2d ago

Job Title: Principal Software Engineer

Job Description

We are seeking an experienced Principal Software Engineer to lead the development of our backend architecture and mobile applications, ensuring compliance with FDA regulations and IEC standards. This role will be instrumental in designing secure, scalable systems that integrate with our biosensor technology. The ideal candidate has a proven track record of launching medical device software products and can work both independently and as part of a multidisciplinary team.

Responsibilities

Architect, develop, and maintain a secure and scalable backend infrastructure for a medical device ecosystem.

Design and implement mobile applications that interface with wearable biosensors via Bluetooth or other wireless protocols.

Ensure compliance with FDA regulations, IEC standards, HIPAA, and cybersecurity best practices.

Lead software development efforts, including coding, testing, and documentation, ensuring high reliability and quality.

Collaborate with firmware, hardware, and regulatory teams to align software with system requirements.

Define and execute software verification and validation in accordance with regulatory standards.

Work with cloud-based technologies for data management, security, and analytics.

Provide technical leadership, mentor junior engineers, and manage software development processes.

Essential Skills

8+ years of experience in software development.

Experience in mobile development for iOS and Android.

Proficiency with Flutter.

Experience with cloud services.

Additional Skills & Qualifications

Expertise in backend development (e.g., Python, Node.js, or C#) and cloud platforms (AWS, Azure, or Google Cloud).

Experience with mobile application development using Flutter, Dart, or similar cross-platform frameworks.

Expertise with communication protocols like Bluetooth Low Energy (BLE), Wi-Fi, or NFC.

Understanding of medical software regulations, including FDA 21 CFR Part 820 and cybersecurity standards.

Strong knowledge in DevOps, CI/CD pipelines, and test automation for regulated environments.

Experience with data privacy, encryption, and secure API development.

Ability to work independently and lead a team through full product lifecycle development.

Strong documentation skills for Design History Files (DHF), Risk Management, and Software Development Lifecycle (SDLC) compliance.

Experience with AI/ML in healthcare applications.

Knowledge of wireless communication security and cybersecurity risk management (ISO, NIST 800-53, OWASP, etc.).

Familiarity with FHIR, HL7, or other healthcare interoperability standards.

Work Environment

The position is based in West Palm Beach, Florida, where the team is building out the site

Pay and Benefits

The pay range for this position is $55.00 - $72.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on May 31, 2025.

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