Software Quality Engineer

Description

At Spectra

WAVE, our mission is bold yet simple: to provide unrivaled optical and computational insights to improve the treatment and outcomes for patients with coronary artery disease (CAD) the leading cause of death worldwide. Our FDA-cleared Hyper Vue™ Imaging System integrates DeepOCT™, near-infrared spectroscopy (NIRS), and advanced machine learning to give interventional cardiologists real-time clarity inside the artery, where it matters most.

Spectra

WAVE recently received FDA 510(k) clearance for X1-FFR, an AI-enabled, wire free, drug-free, single angiogram physiology solution that delivers powerful insights without disrupting workflow. Together, Hyper Vue™ and X1-FFR represent a new era of precision and simplicity in coronary imaging and physiology.

Backed by Johnson & Johnson Innovation – JJDC, Inc. and other leading Med Tech investors, Spectra

WAVE recently completed a $50M Series B funding round to accelerate commercialization and product innovation.

We’re a fast-growing, collaborative team united by the belief that technology can save lives. If you’re inspired by innovation, energized by challenge, and ready to make a measurable impact on patient outcomes, we’d love to meet you.

We are seeking a highly motivated and detail-oriented Software Quality Assurance (SQA) Engineer to join our growing team. In this role, you will contribute to ensuring the safety and reliability of our medical device software through rigorous testing and documentation. This position offers an excellent opportunity to learn and grow within the medical device industry, gaining valuable experience in a regulated environment.

You will work closely with experienced engineers and cross-functional teams to deliver high-quality software that meets stringent regulatory requirements.

• Participate in all aspects of software quality assurance for medical device software including
  • Requirements management
  • Test protocol development and execution
  • Test report creation
  • Automated test development and execution
• Adhere to all applicable regulatory requirements and company quality standards
• Collaborate with software developers, product managers, and other team members to ensure effective communication and problem-solving

• Bachelor's degree in computer science, engineering, or related field
• Basic understanding of software testing concepts and methodologies
• 2 - 5 years' experience working in a product or component test capacity
• Excellent written and verbal communication skills
• Eagerness and ability to learn on the job
• Results oriented

• Familiarity with Python or similar scripting language
• Familiarity with automated software test
• Familiarity with IEC 62304
• Familiarity with medical device development
• Familiarity with bug tracking systems (i.e. JIRA)
• Familiarity with requirements management systems like JAMA
• Ability and Desire to develop and support Python based utilities used by Manufacturing and Field Service
• Ability and Desire to develop proficiency with cybersecurity risk analysis and mitigation per applicable regulatory requirements