Senior Design Assurance Engineer

We are seeking an experienced Senior Design Assurance Engineer with a strong background in software and systems engineering to join our dynamic team. In this role, you will leverage your expertise in design control, risk management, software development, and quality systems to ensure our medical devices, particularly those involving Software as a Medical Device (SaMD), are safe, effective, and compliant with regulatory standards.

If you are ready to take on a challenging and rewarding role that allows you to apply your deep technical knowledge and expertise, apply today and become an integral part of our mission to enhance healthcare and improve patient outcomes!

Essential Duties and Responsibilities:

• Software and Systems Focus:
  • Apply extensive knowledge of Software as a Medical Device (SaMD), including its design, development, usability, compliance, and risk management.
  • Leverage expertise in AI software applications within medical devices to ensure compliance with regulatory standards and safety requirements.
  • Thorough understanding of system and software design controls, participates in cross functional team meetings, software bug triage meetings to discuss, investigate and appropriately disposition internal software bugs and software field issues.
  • Participate in Cybersecurity related discussions and assist supporting activities
  • Assist in the design and development of software test cases and inspection procedures.
  • Understanding of Software Development Life Cycle (SDLC)
• Quality Assurance and Design Control:
  • Ensure safety and effectiveness are integral to the design and maintenance of medical devices through rigorous design control, risk management, quality systems, and change management practices.
  • Support software design control, including usability, risk management, and software compliance throughout the product lifecycle.
• Remediation and Product Work:
  • Lead remediation activities for one specific product, addressing gaps and ensuring compliance with regulatory requirements.
  • Collaborate on product work to embed yourself in the processes, potentially working on skeletal products or platforms such as SWE (Secure View) or Quanta.
• Technical Expertise:
  • Implement and maintain risk management processes throughout the device lifecycle, with a focus on software risk management.
  • Support validation, verification, and clinical preparation activities as required during product development or transfers.
  • Analyze and resolve complex issues creatively and effectively, ensuring innovative solutions align with quality and compliance standards.

Qualifications:

• Education:
  • Bachelor’s Degree in Computer Science, Software Engineering or a related field (Master’s or PhD preferred).
• Experience:
  • 3-5 years of experience in software development for medical devices or other highly regulated industries.
  • Hands-on experience in design control for software in medical devices, including risk management and usability.
  • Proven expertise in quality systems and compliance for regulated products, with a focus on software-related standards and regulations.
  • Experience in conducting and participating in code reviews is preferred.
• Skills:
  • Deep technical knowledge of SaMD, including regulatory requirements such as FDA 21 CFR Part 820 (Design Control), ISO 13485, ISO 14971, and IEC 62304.
  • Strong understanding of software risk management, usability engineering, and compliance processes.
  • Experience with AI software integration into medical devices, including validation and verification.
  • Working knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiments.
• Soft Skills:
  • Ability to effectively collaborate on project teams, take leadership roles, and drive action in accordance with Deming Cycle (PDCA) principles.
  • Strong written and verbal communication skills, with the ability to assess and communicate compliance requirements effectively.

Preferred Certifications:

• ASQ Certified Quality Engineer (CQE)
• Six Sigma Certification
• Familiarity with standards such as IEC 62366 (Usability Engineering), IEC 60601 (Electrical Safety), and IEC 82304 (Health Software).